FDA Adverse Event
Injury
Summary report: N
PROLENE HERNIA SYSTEM MESH
MDR report key: 3191231
·
Received June 26, 2013
Report
- Report Number
- 2210968-2013-11270
- Event Type
- Injury
- Date Received
- June 26, 2013
- Report Date
- June 14, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- K962530
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
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) 2006 AND MESH WAS IMPLANTED INTO THE PATIENT. BS OBTRYX AND PERIGEE ARE ALSO REFERENCED AS POSSIBLE IMPLANTS. NO CLARIFYING INFORMATION IS PROVIDED. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289773 | PROLENE HERNIA SYSTEM MESH | MESH, SURGICAL, SYNTHETIC | FTL | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |