FDA Adverse Event
Malfunction
Summary report: N
IN-FAST ULTRA KIT
MDR report key: 505789
·
Received October 17, 2003
Report
- Report Number
- 505789
- Event Type
- Malfunction
- Date Received
- October 17, 2003
- Report Date
- October 1, 2003
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- FHK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN-FAST ULTRA KIT | VAGINAL SLING | FHK | AMERICAN MEDICAL SYSTEMS | 72403885 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | NOT KNOWN. |