FDA Adverse Event
Other
Summary report: N
ZASSI BOWEL MANAGEMENT SYSTEM
MDR report key: 920854
·
Received September 27, 2007
Report
- Report Number
- 1480288-2007-00005
- Event Type
- Other
- Date Received
- September 27, 2007
- Date of Event
- July 24, 2007
- Report Date
- August 14, 2007
- Manufacturer
- HOLLISTER INCORPORATED
- Product Code
- KNT
- PMA / PMN Number
- K023344
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RN ATTEMPTED TO FLUSH ZASSI BOWEL MANAGEMENT SYSTEM AND NOTED MAJOR LEAKAGE OF STOOL. RN REMOVED FLUID FROM THE BALLOON AND ATTEMPTED TO REMOVE THE ZASSI FROM THE PATIENTS RECTUM, BUT MET RESISTANCE. UNABLE TO REMOVE ZASSI FROM THE PATIENTS RECTUM, AND SO IT WAS REMOVED DIGITALLY. AFTER REMOVAL THE RN NOTED THE ZASSI TO BE BROKEN IN 2 PIECES AT THE INSERTION SITE. PATIENT WITHOUT INJURY AND DID NOT REQUIRE ADDITIONAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZASSI BOWEL MANAGEMENT SYSTEM | ZASSI | KNT | HOLLISTER INCORPORATED | 7B32C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |