FDA Adverse Event
Injury
Summary report: N
GYNECARE MESH UNKNOWN
MDR report key: 3904458
·
Received July 1, 2014
Report
- Report Number
- 2210968-2014-08457
- Event Type
- Injury
- Date Received
- July 1, 2014
- Report Date
- June 26, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- OTO
- PMA / PMN Number
- UNKNOWN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
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.
Description of Event or Problem · 1
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH TVH DUE TO POP. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 384520 | GYNECARE MESH UNKNOWN | OTO | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |