FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 2722221
·
Received August 28, 2012
Report
- Report Number
- 2017233-2012-00578
- Event Type
- Injury
- Date Received
- August 28, 2012
- Date of Event
- July 1, 2005
- Report Date
- August 5, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SPECIFIC PATIENT AND DEVICE INFORMATION WAS NOT PROVIDED IN THE ARTICLE. GORE HAS REQUESTED ADDITIONAL INFORMATION FROM THE AUTHOR. ADAM KOLKER, DANIEL J. BROWN ET AL. MULTILAYER RECONSTRUCTION OF ABDOMINAL WALL DEFECTS WITH ACELLULAR DERMAL ALLOGRAFT (ALLODERM) AND COMPONENT SEPARATION ANNALS OF PLASTIC SURGERY 2005; 55-36-42.
Description of Event or Problem · 1
REVIEW OF JOURNAL ARTICLE ENTITLED, "MULTILAYER RECONSTRUCTION OF ABDOMINAL WALL DEFECTS WITH ACELLULAR DERMAL ALLOGRAFT (ALLODERM) AND COMPONENT SEPARATION" DESCRIBES FOUR PATIENTS WITH INFECTIONS THAT UNDERWENT MESH REMOVAL FOLLOWED BY DEBRIDEMENT AND IRRIGATION. TWO OF THE PATIENTS ALSO HAD SUBATMOSPHERIC PRESSURE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | NONE | FTL | W.L. GORE & ASSOCIATES,INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |