FDA Adverse Event
Malfunction
Summary report: N
A&E MEDICAL MYOWIRE IIA&E MEDICAL MYOWIRE II
MDR report key: 4976121
·
Received July 22, 2015
Report
- Report Number
- 4976121
- Event Type
- Malfunction
- Date Received
- July 22, 2015
- Date of Event
- July 21, 2015
- Report Date
- July 22, 2015
- Manufacturer
- ALTO DEVELOPMENT CORP
- Product Code
- GAO
- Product Problem
- Yes
- Report Source
- User Facility report
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476747 | A&E MEDICAL MYOWIRE IIA&E MEDICAL MYOWIRE II | SUTURE, NONABSORBABLE, STEEL | GAO | ALTO DEVELOPMENT CORP | * | 0560S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | 52 YR |