FDA Adverse Event
Malfunction
Summary report: N
CONVATEC
MDR report key: 2182610
·
Received July 14, 2011
Report
- Report Number
- 2182610
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 14, 2011
- Manufacturer
- CONVATEC
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
Narratives
Description of Event or Problem · 1
A FLEXI SEAL FECAL MANAGEMENT DEVICE WAS NEEDED FOR A PT. AFTER INSERTING THE PRODUCT INTO THE RECTUM, IT WAS DISCOVERED THAT THE BALLOON PORT FOR INFLATION HAD FALLEN OFF OF THE DEVICE. THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS PULLED FROM STOCK. THE SECOND DEVICE WAS CHECKED BEFORE INSERTION AND FOUND TO HAVE THE SAME DEFECT WITH THE BALLOON PORT FALLING OFF OF THE DEVICE. A THIRD DEVICE WAS PULLED FROM STOCK AND WAS FOUND TO BE OKAY AND USED SUCCESSFULLY ON THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONVATEC | FECAL MANAGEMENT DEVICE | KNT | CONVATEC | FLEXI SEAL | 10-FM-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |