FDA Adverse Event
Other
Summary report: N
INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10
MDR report key: 2170106
·
Received June 20, 2011
Report
- Report Number
- 1121308-2011-00021
- Event Type
- Other
- Date Received
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- INTEGRA, PLAINSBORO
- Product Code
- GXQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE PRODUCT WAS APPLIED TO A PT WHO HAD APPROXIMATELY 80% SURFACE AREA BURNS TO HIS BODY. THE DAY AFTER THE DEVICE WAS USED, THE DOCTOR HAD A EXCISE A SMALL SPOT OF INTEGRA OVER THE TORSO BECAUSE IT LOOKED LIKE THERE WAS A FUNGAL INFECTION. THE PROBABLE LOT NUMBER OF THE PRODUCT THAT WAS REMOVED HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10 | BWD-MESHED | GXQ | INTEGRA, PLAINSBORO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |