FDA Adverse Event
Other
Summary report: N
BILAYER MATRIX WOUND 4X10 SINGLE SHEET
MDR report key: 1221631
·
Received November 4, 2008
Report
- Report Number
- 1121308-2008-00018
- Event Type
- Other
- Date Received
- November 4, 2008
- Date of Event
- October 8, 2008
- Report Date
- November 14, 2008
- Manufacturer
- INTEGRA LIFESCIENCES
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT A DEVICE THAT HAD PASSED ITS EXPIRATION DATE WAS PLACED ON A PATIENT DURING A WOUND DEBRIDEMENT PROCEDURE. THE EXPIRATION DATE WAS NOT CHECKED PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BILAYER MATRIX WOUND 4X10 SINGLE SHEET | BILAYER MATRIX WOUND DRESSING | NAD | INTEGRA LIFESCIENCES | 105BB0074324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |