FDA Adverse Event
Injury
Summary report: N
MYO/WIRE II
MDR report key: 485724
·
Received September 25, 2003
Report
- Report Number
- 2242056-2003-00005
- Event Type
- Injury
- Date Received
- September 25, 2003
- Report Date
- September 24, 2003
- 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
STERNAL WIRES WERE REMOVED DUE TO BREAKAGE AND REPLACED WITH NEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MYO/WIRE II | STAINLESS STEEL SUTURE | GAQ | ALTO DEVELOPMENT CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |