FDA Adverse Event
Malfunction
Summary report: N
3M PRECISE DISPOSABLE SKIN STAPLER
MDR report key: 6760048
·
Received July 31, 2017
Report
- Report Number
- MW5071327
- Event Type
- Malfunction
- Date Received
- July 31, 2017
- Date of Event
- July 31, 2017
- Report Date
- July 31, 2017
- Manufacturer
- 3M HEALTH CARE
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
TWO SKIN STAPLERS JAMMED AND STOPPED WORKING. LOT #17FB7530 STAPLER SKIN PGX-35W; 3M PRECISE DISPOSABLE SKIN STAPLER #PGX-35W LOT # 2022-01JZ.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535541 | 3M PRECISE DISPOSABLE SKIN STAPLER | SKIN STAPLER | GDW | 3M HEALTH CARE | PGX-35W | 17FB7530 | |
| 535542 | 3M PRECISE DISPOSABLE SKIN STAPLER | SKIN STAPLER | GDW | 3M HEALTH CARE | 2022-01JZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |