FDA Adverse Event
Injury
Summary report: N
GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM
MDR report key: 3232528
·
Received July 18, 2013
Report
- Report Number
- 2210968-2013-13562
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- November 1, 2016
- 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO CYSTOCELE, RECTOCELE, POP. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
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.
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. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333486 | GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | UNK | 3405572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |