FDA Adverse Event
Malfunction
Summary report: N
FREEMAN-GORNEY RHYTIDECTOMY SCISSORS, SUR
MDR report key: 496687
·
Received November 17, 2003
Report
- Report Number
- 1910735-2003-00038
- Event Type
- Malfunction
- Date Received
- November 17, 2003
- Report Date
- November 17, 2003
- Manufacturer
- PADGETT INSTRUMENTS, INC.
- Product Code
- HRR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BOUGHT 2 NEW PADGETT SUPER CUT SCISSORS FOR FACE LIFT FROM THE SALES REPRESENTATIVE. ALTHOUGH THE SCISSORS ARE NEW THEY DIDN'T CUT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED IN 2003 THAT THESE INSTRUMENTS WERE IN CONTACT WITH PATIENTS ALTHOUGH NO INJURIES HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEMAN-GORNEY RHYTIDECTOMY SCISSORS, SUR | PADGETT SCISSORS | HRR | PADGETT INSTRUMENTS, INC. | P-6835 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |