FDA Adverse Event
Malfunction
Summary report: N
DURAGEN 1X3 5 PACK DOMESTIC
MDR report key: 2481554
·
Received March 5, 2012
Report
- Report Number
- 1121308-2012-00008
- Event Type
- Malfunction
- Date Received
- March 5, 2012
- Report Date
- March 5, 2012
- Manufacturer
- INTEGRA LIFESCIENCES CORP
- Product Code
- GXQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
DURAGEN (B)(4) IN THE ORIGINAL PACKAGING, WAS DESCRIBED AS BEING "SPOILED" (THE COLOR WAS YELLOW). THERE WAS NO PT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURAGEN 1X3 5 PACK DOMESTIC | NA | GXQ | INTEGRA LIFESCIENCES CORP | 1110668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |