FDA Adverse Event
Malfunction
Summary report: N
CENTER POINT LEAK WITH FLOATING FLANGE, SKIN BARRIER WITH TAPE
MDR report key: 1630793
·
Received March 12, 2010
Report
- Report Number
- MW5015097
- Event Type
- Malfunction
- Date Received
- March 12, 2010
- Date of Event
- March 1, 2008
- Report Date
- March 12, 2010
- Manufacturer
- HOLLISTER, INC. (HOLLISTER)
- Product Code
- EXE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
POUCH POPS OFF FACEPLATE, WONT STAY ON. MANUFACTURER MUST HAVE REALIZED THIS PRODUCT WAS FAULTY WHEN PUTTING IT ON THE MARKET. HAVE BEEN EXPERIENCING THIS PROBLEM FOR A COUPLE OF YEARS WITH DIFFERENT LOT NUMBERS OF SAME PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTER POINT LEAK WITH FLOATING FLANGE, SKIN BARRIER WITH TAPE | EXE | HOLLISTER, INC. (HOLLISTER) | 3724 | 96302 | ||
| 2 | DRAINABLE POUCH WITH CLAMP-2 PIECE OSTONY SYSTEM | EXB | HOLLISTER, INC. (HOLLISTER) | 3804 | 7L132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |