FDA Adverse Event
Injury
Summary report: N
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
MDR report key: 3180456
·
Received June 20, 2013
Report
- Report Number
- 2210968-2013-10675
- Event Type
- Injury
- Date Received
- June 20, 2013
- Report Date
- June 19, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTP
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IN ADDITION, 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 A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. AFTER THE SURGERY THE PATIENT HAD LASTING PAIN IN THE GROIN AND BUTTOCK WITH RADIATING PAIN TO THE HIP AND LEG. THE PATIENT UNDERWENT A REOPERATION ON (B)(6) 2009 AND 1STRAP FROM THE MESH WAS REMOVED. THE PAIN DID NOT STOP. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279938 | GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | UNK | 3238547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |