FDA Adverse Event
Injury
Summary report: N
GYNECARE GYNEMESH* PS
MDR report key: 3240737
·
Received July 22, 2013
Report
- Report Number
- 2210968-2013-13979
- Event Type
- Injury
- Date Received
- July 22, 2013
- Report Date
- July 8, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTO
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: 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
DATE SENT TO THE FDA: 01/28/2014. IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN AND INCONTINENCE ALMOST IMMEDIATELY FOLLOWING THE PROCEDURE. THE PATIENT UNDERWENT A PARTIAL EXPLANT OF THE MESH AND STILL SUFFERS FROM NERVE PAIN AND UNSTABLE BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341857 | GYNECARE GYNEMESH* PS | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTO | ETHICON INC. | UNK | ZLB416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |