FDA Adverse Event
Injury
Summary report: N
AMERICAN MEDICAL SYSTEMS
MDR report key: 803629
·
Received January 10, 2007
Report
- Report Number
- MW1041594
- Event Type
- Injury
- Date Received
- January 10, 2007
- Date of Event
- January 8, 2007
- Report Date
- January 8, 2007
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- FTL
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PERIGEE IMPLANT NEEDLE PULLED OFF MESH AS NEEDLE WAS PUSHED THROUGH TISSUE. ADDITIONAL DEVICE UTILIZED TO SECURE MESH TO NEW NEEDLE. PROCEDURE COMPLETED WITHOUT ADDITIONAL INTERVENTION. DEVICE GIVEN TO COMPANY REP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN MEDICAL SYSTEMS | PERIGEE SYSTEM WITH INTEPRO | FTL | AMERICAN MEDICAL SYSTEMS | 72404210 | 469523003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization |