FDA Adverse Event
Summary report: N
SURGICAL STEEL
MDR report key: 26146
·
Received July 24, 1995
Report
- Report Number
- 26146
- Date Received
- July 24, 1995
- Manufacturer
- ETHICON
- Product Code
- GAQ
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
WHILE CLOSING THE STERNUM WITH STEEL WIRE SUTURES, THE TIP OF ONE OF THE STERNAL WIRE NEEDLES BROKE OFF IN THE STERNUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL STEEL | SURGICAL STEEL | GAQ | ETHICON | M-655 | HBP161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |