FDA Adverse Event
Injury
Summary report: N
GYNECARE PROLIFT +M PELVIC FLOOR REPAIR SYSTEM
MDR report key: 3233826
·
Received July 18, 2013
Report
- Report Number
- 2210968-2013-13672
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- November 8, 2017
- Manufacturer
- ETHICON INC.
- Product Code
- OTP
- PMA / PMN Number
- K071512
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335518 | GYNECARE PROLIFT +M PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention | MINI ARC| MONARC |