FDA Adverse Event
Injury
Summary report: N
PORTRAIT PSR3
MDR report key: 1060873
·
Received June 13, 2008
Report
- Report Number
- 3004948955-2008-00020
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 23, 2008
- Manufacturer
- RHYTEC INCORPORATED
- Product Code
- GEI
- PMA / PMN Number
- K071786
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO CULTURE WAS TAKEN OF THE INFECTION. THE MEDICAL STAFF AT THE PHYSICIAN'S OFFICE SAW THE PT AFTER SHE WENT TO THE ER AND DID NOT BELIEVE, SHE HAD AN INFECTION.
Description of Event or Problem · 1
PT TREATED WITH PORTRAIT PSR3 BELIEVED, SHE DEVELOPED AN INFECTION UNDER EACH EYE AND WENT TO HER LOCAL EMERGENCY ROOM FOR TREATMENT. ERYTHROMYCIN WAS PRESCRIBED. THE PT WAS SEEN ON FOUR DAYS LATER, AND THE "INFECTION" APPARENTLY CLEARED UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTRAIT PSR3 | ELECTROSURGICAL CUTTING AND COAGULATION | GEI | RHYTEC INCORPORATED | 74500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |