FDA Adverse Event
Injury
Summary report: N
MYO/WIRE II
MDR report key: 369210
·
Received December 27, 2001
Report
- Report Number
- 2242056-2001-00005
- Event Type
- Injury
- Date Received
- December 27, 2001
- Date of Event
- December 12, 2001
- Report Date
- December 26, 2001
- Manufacturer
- ALTO DEVELOPMENT CORP
- Product Code
- GAQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WIRES INSTALLED IN 2001. FOUR MONTHS LATER, WIRES WERE REMOVED DUE TO BREAKAGE AND REPLACED WITH NEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58999 | MYO/WIRE II | STAINLESS STEEL SUTURE | GAQ | ALTO DEVELOPMENT CORP | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |