Type of Device | UNKNOWN |
Manufacturer (Section D) |
APYX MEDICAL CORPORATION |
5115 ulmerton road |
clearwater, fl |
|
Manufacturer Contact |
april
baures
|
5115 ulmerton road |
clearwater, fl
|
3842323855
|
|
MDR Report Key | 10097449 |
MDR Text Key | 192454918 |
Report Number | 3007593903-2020-00020 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial |
Report Date |
05/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/28/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 05/29/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/09/2003 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Disability;
|
|
|