FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
MDR report key: 3211406
·
Received July 8, 2013
Report
- Report Number
- 2210968-2013-12451
- Event Type
- Injury
- Date Received
- July 8, 2013
- Report Date
- January 13, 2017
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- K962530
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO CYSTOCELE AND UTERINE PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative · 1
(B)(4).
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.
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) 2007 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 |
|---|---|---|---|---|---|---|---|
| 311437 | PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT | MESH, SURGICAL, POLYMERIC | FTL | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |