FDA Adverse Event
Malfunction
Summary report: N
CONVERTORS TIBURON
MDR report key: 835702
·
Received March 6, 2007
Report
- Report Number
- 835702
- Event Type
- Malfunction
- Date Received
- March 6, 2007
- Date of Event
- March 3, 2007
- Report Date
- March 6, 2007
- Manufacturer
- CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
- Product Code
- KKX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- GA, US
Narratives
Description of Event or Problem · 1
DRAPE DID NOT MAINTAIN A STERILE BARRIER BY ALLOWING FLUID TO PENETRATE THE MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONVERTORS TIBURON | DRAPE, SURGICAL | KKX | CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |