FDA Adverse Event
Injury
Summary report: N
MESH BALLYMONEY - IVS TUNNELLER¿
MDR report key: 9606649
·
Received January 20, 2020
Report
- Report Number
- 6000141-2020-00001
- Event Type
- Injury
- Date Received
- January 20, 2020
- Report Date
- January 20, 2020
- Manufacturer
- TYCO HEALTHCARE UK MANF. LTD
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF ENTEROCELE, CYSTOCELE, RECTOCELE, MIXED URINARY INCONTINENCE, STRESS URINARY INCONTINENCE, MENOMETRORRHAGIA, AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. THE DEVICE HAD BEEN USED WITH TAB884 GYNECARE GYNEMESH PS (LOT# GPSLL02) AND 810081 GYNECARE TVT OBTURATOR (LOT# 1152877).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71435 | MESH BALLYMONEY - IVS TUNNELLER¿ | MESH, SURGICAL, POLYMERIC | FTL | TYCO HEALTHCARE UK MANF. LTD | IVS02 | 0302038-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |