GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
Report
- Report Number
- 2210968-2015-19060
- Event Type
- Injury
- Date Received
- February 24, 2016
- Report Date
- November 10, 2015
- Manufacturer
- ETHICON INC.
- Product Code
- OTP
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. E2013037. TOTAL NUMBER OF EVENTS: 374. GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM 13. GYNECARE PROLIFT +M PELVIC FLOOR REPAIR SYSTEM 18. GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM 9. GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM 35. GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM 40. GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM 147. GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM 24. GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM 58. GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM 13. GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS 17.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ADDITIONAL F-10 PATIENT CODES: 1928, 1930, 2060, 2597, 3191. ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD (B)(4) 2015 THROUGH (B)(4) 2016.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
IT WAS REPORTED BY ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 CONCURRENTLY WITH BLADDER HYDRODISTENTION AND PERINEOPLASTY AND MESH WAS IMPLANTED. IT WAS REPORTED THAT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REMOVAL ON (B)(6) 2013 DUE TO RECTAL PROLAPSE, DYSPAREUNIA AND EROSION.
DATE SENT TO FDA: 04/24/2019. ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
DATE SENT TO FDA: 12/27/2018. ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
DATE SENT TO FDA: 02/12/2019. ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037. REPORTING PERIOD DECEMBER 1, 2015 THROUGH JANUARY 31, 2016.
DATE SENT TO FDA: (B)(4) 2018. ETHICON MDR SUMMARY REPORTING EXEMPTION E2013037REPORTING PERIOD (B)(4) 2015 THROUGH (B)(4) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114778 | GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | UNK | 3515542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |