FDA Adverse Event
Injury
Summary report: N
ZASSI BOWEL MANAGEMENT SYSTEM
MDR report key: 858574
·
Received May 30, 2007
Report
- Report Number
- 1480288-2007-00002
- Event Type
- Injury
- Date Received
- May 30, 2007
- Manufacturer
- HOLLISTER, INC.
- Product Code
- KNT
- PMA / PMN Number
- K023344
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS SHOWING EVIDENCE OF ALCOHOL RELATED, LIVER CIRRHOSIS. TWENTY-FOUR DAYS AFTER THE BOWEL MANAGEMENT DEVICE WAS INSERTED, THE PT DEVELOPED RECTAL BLEEDING. THE DEVICE WAS REMOVED AND AN ENDOSCOPY WAS PERFORMED. IT WAS DETERMINED AN ULCERATION OF THE RECTAL WALL HAD DEVELOPED. THE ULCER WAS EMBOLIZED AND THE BLEEDING FROM THE ULCERATION STOPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZASSI BOWEL MANAGEMENT SYSTEM | RECTAL CATHETER | KNT | HOLLISTER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Life Threatening |