FDA Adverse Event
Injury
Summary report: N
GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM
MDR report key: 3203058
·
Received July 2, 2013
Report
- Report Number
- 2210968-2013-11976
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- June 24, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTP
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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) 2009 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301115 | GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |