FDA Adverse Event
Injury
Summary report: N
ULTRAPRO MESH
MDR report key: 2770861
·
Received October 3, 2012
Report
- Report Number
- 2210968-2012-05985
- Event Type
- Injury
- Date Received
- October 3, 2012
- Report Date
- September 13, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K033337
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION: NARRATIVE - IT WAS REPORTED THAT THE PATIENT IS STILL AWAITING HERNIA REPAIR PROCEDURE. THE SURGEON OPINES THAT THE CAUSE AND CONTRIBUTING FACTORS FOR THE HERNIA RECURRENCE WAS THAT THE MESH WAS NOT PROTECTED WITH ANTERIOR FASCIA.
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 HAD A HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. DURING A FOLLOW UP APPOINTMENT, THE SURGEON FEELS THE MESH HAS TORN. THE PATIENT WILL REQUIRE A RE-OPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAPRO MESH | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |