FDA Adverse Event
Injury
Summary report: N
STL MF K-61 IN 30"X2
MDR report key: 382485
·
Received March 18, 2002
Report
- Report Number
- 1221601-2002-00003
- Event Type
- Injury
- Date Received
- March 18, 2002
- Report Date
- March 18, 2002
- Manufacturer
- GENZYME BIOSURGERY A DIVISION OF GER
- Product Code
- GAQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER ALLEGES THE STEEL SUTURE NEEDLE BROKE IN HALF WHILE TRYING TO CLOSE THE STERNUM. THE CUSTOMER USED X-RAY TO RECOVER THE BROKEN PARTS. THERE WAS NO INJURY TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STL MF K-61 IN 30"X2 | STAINLESS STEEL SUTURE | GAQ | GENZYME BIOSURGERY A DIVISION OF GER | E2-5367M2 | 352803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |