FDA Adverse Event
Injury
Summary report: N
MESH TSL - PELVICOL¿
MDR report key: 7897945
·
Received September 21, 2018
Report
- Report Number
- 9617613-2018-00102
- Event Type
- Injury
- Date Received
- September 21, 2018
- Report Date
- September 21, 2018
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
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 UROGYNECOLOGICAL ISSUES. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT GENUINE STRESS URINARY INCONTINENCE, RECURRENT CYSTOCELE, ANXIETY, URINARY TRACT INFECTION, HEMATURIA. THE DEVICE HAD BEEN USED WITH 810041 TVT, LOT 982065.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740151 | MESH TSL - PELVICOL¿ | MESH, SURGICAL, POLYMERIC | FTL | TISSUE SCIENCE LABORATORIES | 482047 | 02A21B530077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |