FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT OBURATOR SYSTEM
MDR report key: 3241385
·
Received July 22, 2013
Report
- Report Number
- 2210968-2013-14006
- Event Type
- Injury
- Date Received
- July 22, 2013
- Report Date
- January 17, 2017
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative · 1
(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
DATE SENT TO FDA: 1/19/2017.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009, MESH WAS IMPLANTED CONCURRENTLY WITH POSTERIOR REPAIR AND PERINEORRHAPHY, FOR STRESS URINARY INCONTINENCE, SECOND DEGREE RECTOCELE AND PERINEAL RELAXATION. PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341232 | GYNECARE TVT OBURATOR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | UNK | 3283319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |