FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE PROXIMATE PLUS MD SKIN STAPLER
MDR report key: 296549
·
Received September 13, 2000
Report
- Report Number
- 1527736-2000-04341
- Event Type
- Malfunction
- Date Received
- September 13, 2000
- Date of Event
- July 12, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDT
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
IT WAS REPORTED ON AN EXTERNAL MEDWATCH #210012-2000-0007 THAT THE ONE PMW35 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SKIN STAPLER STUCK DURING CLOSING. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PROXIMATE PLUS MD SKIN STAPLER | SKIN STAPLERS | GDT | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |