FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT OBURATOR SYSTEM
MDR report key: 3163347
·
Received June 11, 2013
Report
- Report Number
- 2210968-2013-10169
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 3, 2016
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- 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
IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT HYSTEROSCOPY, ENDOMETRIAL ABLATION, AND DIAGNOSTIC CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE, DYSFUNCTIONAL UTERINE BLEEDING AND MENORRHAGIA.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264102 | GYNECARE TVT OBURATOR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | UNK | 3374633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |