FDA Adverse Event
Injury
Summary report: N
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
MDR report key: 3233857
·
Received July 18, 2013
Report
- Report Number
- 2210968-2013-13679
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- December 19, 2013
- 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
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED CONCURRENTLY WITH RECTOCELE REPAIR, B/L EXTRAPERITONEAL SACROSPINOUS LIGAMENT SUSPENSION OF THE UTERUS AND THE VAGINAL VAULT AND ANAL SPHINCTEROPLASTY DUE TO RECURRENT STAGE 2 RECTOCELE AND FECAL INCONTINENCE.
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.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 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 |
|---|---|---|---|---|---|---|---|
| 335828 | GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | 1345419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |