FDA Adverse Event
Malfunction
Summary report: N
BMWD 8X10 1 PACK
MDR report key: 2012161
·
Received February 1, 2011
Report
- Report Number
- 1121308-2011-00002
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 4, 2011
- Report Date
- February 1, 2011
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- NAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE INVESTIGATION OF THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE REPORTER STATED THAT ONE SHEET OF A FIVE COUNT BILAYER MATRIX WOUND DRESSING PACKAGE HAD A TEAR IN THE INNER POUCH. IT WAS NOTICED AT THE TIME THAT IT WAS BEING PLACED ON THE STERILE FIELD. THE PRODUCT WAS NOT PLACED ON THE STERILE FIELD. THE PRODUCT WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BMWD 8X10 1 PACK | NA | NAD | INTEGRA LIFESCIENCES CORPORATION | 105EA0200671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |