FDA Adverse Event
Injury
Summary report: N
PORTRAIT PSR3
MDR report key: 1143631
·
Received August 28, 2008
Report
- Report Number
- 3004948955-2008-00031
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 6, 2008
- Manufacturer
- RHYTEC INC
- Product Code
- GEI
- PMA / PMN Number
- K071786
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN'S GUIDE WARNINGS INCLUDE THE RISK OF INFECTION AFTER THE PROCEDURE. THE PHYSICIAN FOLLOWED AND TREATED THE PATIENT.
Description of Event or Problem · 1
PATIENT DEVELOPED A STAPH AUREUS INFECTION IN THE AREA TREATED. KEFLEX WAS PRESCRIBED BY THE TREATING PHYSICIAN. THIRTEEN DAYS AFTER INITIAL TREATMENT THE PATIENT IS REPORTED HEALING WITH NO FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTRAIT PSR3 | ELECTROSURGICAL CUTTING AND COAGULATION | GEI | RHYTEC INC | 745000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |