FDA Adverse Event
Injury
Summary report: N
PORTRAIT PSR3
MDR report key: 1003973
·
Received February 22, 2008
Report
- Report Number
- 3004948955-2008-00013
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- December 28, 2007
- Report Date
- January 24, 2008
- Manufacturer
- RHYTEC INCORPORATED
- Product Code
- GEI
- PMA / PMN Number
- K071786
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PORTRAIT PSR DOES NOT CONTACT THE PT DURING USE. LABELING STATES THAT FOLLOWING THE PROCEDURE, THE TREATED SITE MAY BE SUBJECT TO AN OPPORTUNISTIC INFECTION.
Description of Event or Problem · 1
PT TREATED WITH PORTRAIT PSR DEVELOPED AN INFECTION AFTER TREATMENT. ANTIBIOTICS WERE PRESCRIBED AND THE INFECTION CLEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTRAIT PSR3 | ELECTROSURGICAL CUTTING AND COAGULATION | GEI | RHYTEC INCORPORATED | 745000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |