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RENUVION®
J-PLASMA®
Electronic IFU Portal
Electronic IFU Portal
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COMPANY
OVERVIEW
QUALITY
CAREERS
PRODUCTS
RENUVION®
J-PLASMA®
Electronic IFU Portal
Electronic IFU Portal
INVESTOR RELATIONS
BLOG
Customer Feedback
Customer Feedback
1. Reporter (Your) Information
Your Name
*
First
Last
Today's Date
*
Date Format: MM slash DD slash YYYY
Your Phone Number
*
Your Email
*
2. Health Provider Information
Health Provider Name
*
First
Last
Medical/Surgical Specialty
*
Practice Name
*
City/State
*
City
State / Province / Region
Postal Code
*
ZIP / Postal Code
Country
*
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo, Democratic Republic of the
Congo, Republic of the
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini (Swaziland)
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Korea
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russia
Rwanda
Réunion
Saint Barthélemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia
South Korea
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen Islands
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
US Minor Outlying Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands
Country
Phone Number
*
Fax Number
Email
*
3. Device Information (list all products associated with the event)
Electrosurgical Unit
Electrosurgical Unit – Catalog #:
Electrosurgical Unit – Device Name:
Electrosurgical Unit – Serial Number:
Electrosurgical Unit – Settings:
Grounding Pad Used:
Solid Pad
Split Pad
Where was the grounding pad placed?
Is the device available for evaluation?
Yes
No
N/A
Handpiece
Handpiece – Catalog #:
Handpiece – Device Name:
Handpiece – Lot Number:
Is the device available for evaluation?
Yes
No
N/A
Accessories
Accessories – Catalog #:
Accessories – Device Name:
Accessories – Lot Number:
Is the device available for evaluation?
Yes
No
N/A
Was device used on the patient?
*
YES
NO
Was this the first time this device was used?
*
YES
NO
If a sterile device, had it been reprocessed and/or re-sterilized?
YES
NO
Physician Provider Experience with Renuvion® and/or J-Plasma® Technology (select one):
*
Less than 10 procedures
11-20 procedures
20-50 procedures
50+ procedures
Other Medical Devices Used (e.g. Vaser)
Other Medical Device – Catalog #:
Other Medical Device – Device Name:
Other Medical Device – Lot Number:
Other Medical Device – Description:
4. Incident Information
Date of Incident
*
Date Format: MM slash DD slash YYYY
Nature of Problem Encountered:
*
Attach any photos or videos of the incident:
Drop files here or
Was there patient injury?
*
YES
NO
If yes, describe:
*
Approximate size of complication (e.g. lesion or burn):
*
When did complication first appear?
*
Was there user injury?
*
YES
NO
If yes, describe:
*
Did the Device Function as Intended?
*
YES
NO
If no, answer the following questions:
• When did issue/malfunction/injury occur?
*
Straight out of the box
0-10 min into the case
10-30 min into the case
30-60 min into the case
• Characterization of device problem (select all that apply and enter additional details below):
*
Packaging damage
Device visual damage or breakage
Third ChoiceMoving part jammed (blade extension/retraction activation button, other buttons)
Generator Error or Fault Code. Enter Error Code below.
Unusual plasma flow (no flow, low flow, intermittent flow)
• Device Problem – Additional Details
*
Measures Taken to Correct Problem:
*
In the opinion of the health care professional, did the device(s) cause or contribute to the incident?
*
YES
NO
Was MedWatch Form filed with FDA by facility?
*
YES
NO
5. Patient Information
Operative Notes/Treatment Records available?
*
YES
NO
Patient ID # and/or Initials:
*
Patient Gender:
*
Age at Time of Event:
*
Patient Medical History:
*
Current Patient Condition (Status):
*
Patient Treatment:
*
Date(s) of Post Op Evaluation:
*
6. Procedure Information
Type of Procedure Being Performed on Patient:
*
Laparoscopic
General Surgery
Cosmetic Surgery
Subdermal Coagulation
Generator Settings Used (%, Flow):
*
Complete the section below only for Subdermal Coagulation Procedures.
List other previous procedures done in the treatment area: (e.g. type of liposuction, fillers, sutures, energy based procedures, surgical lifting, etc.)
*
Location of insertion sites:
*
Infiltration amount infused:
*
And at what temperature:
*
Undermining performed with (Instrument):
*
Additional treatment with details: (e.g.: VASER settings (continuous or pulsed), minutes delivered, cannula size)
*
Aspiration performed:
*
Aspiration amount:
*
Length of aspiration time:
*
Treatment plane (depths): (e.g.: One intermediate or two, one superficial one deep.)
*
Number of passes:
*
Were temperatures monitored?
*
YES
NO
If yes, with what device?
*
Was compression applied?
*
YES
NO
If yes, when and how long?
*
Immediate treatment plan: (e.g.: Creams or ointments, RX Silvadene, continued compression, injections, masks etc.)
*
Are you a Apyx™ Medical employee?
*
YES
NO
7. Apyx Medical Personnel Only
Awareness Date (date event was first reported to you):
*
Date Format: MM slash DD slash YYYY
Did health care professional state device(s) caused or contributed to the incident?
*
YES
NO
If yes, provide details:
*
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