FDA Adverse Event
Injury
Summary report: N
PROCEED VENTRAL PATCH
MDR report key: 1844891
·
Received September 22, 2010
Report
- Report Number
- 2210968-2010-01183
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 23, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K061533
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - HERNIA RECURRED: CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN UMBILICAL HERNIA REPAIR ON (B)(6)2009 AND MESH WAS PLACED. THE PT RETURNED TO THE SURGEON ON (B)(6)2010 WITH A RECURRENT HERNIA. ADDITIONAL INFO REQUESTED. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROCEED VENTRAL PATCH | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |