FDA Adverse Event
Injury
Summary report: N
MESH SOFRADIM - UGYTEX¿
MDR report key: 7659345
·
Received July 3, 2018
Report
- Report Number
- 9615742-2018-01450
- Event Type
- Injury
- Date Received
- July 3, 2018
- Report Date
- July 3, 2018
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- PMA / PMN Number
- K051503
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
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 DYSMENORRHEA, 3RD DEGREE UTERINE PROLAPSE, 2ND DEGREE CYSTOCELE AND 2ND DEGREE RECTOCELE. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. TREATMENT AND POTENTIALLY RELATED PROCEDURES INCLUDE REVISION. AFTER TREATMENT, THE PATIENT EXPERIENCED DYSMENORRHEA, 3RD DEGREE UTERINE PROLAPSE, 2ND DEGREE CYSTOCELE AND 2ND DEGREE RECTOCELE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500130 | MESH SOFRADIM - UGYTEX¿ | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | UGYKP | ZQH00287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R |