FDA Adverse Event
Injury
Summary report: N
PROLIFT PELVIC FLOOR REPAIR
MDR report key: 3043468
·
Received April 9, 2013
Report
- Report Number
- 2210968-2013-03648
- Event Type
- Injury
- Date Received
- April 9, 2013
- Report Date
- March 18, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- OTP
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2005. THE PATIENT EXPERIENCED AN EXTRUSION OF THE DEVICE. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH A VAGINAL EROSION ASSOCIATED WITH URINARY FREQUENCY AND A CHRONIC URINARY RETENTION AND UNDERWENT A VISCERAL SURGERY. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2013 FOR A PARTIAL EXPLANT OF THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145537 | PROLIFT PELVIC FLOOR REPAIR | MESH, SURGICAL, POLYMERIC | OTP | ETHICON, INC. | NA | 1302689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |