FDA Adverse Event
Other
Summary report: N
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM
MDR report key: 1546247
·
Received November 25, 2009
Report
- Report Number
- 1480288-2009-00008
- Event Type
- Other
- Date Received
- November 25, 2009
- Date of Event
- October 27, 2009
- Report Date
- November 25, 2009
- Manufacturer
- HOLLISTER, INC.
- Product Code
- KNT
- PMA / PMN Number
- K083153
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED BY THE DIRECTOR OF NURSING THAT THE PT WAS KNOWN TO HAVE RECTAL FISSURES PRIOR TO THE INSERTION OF THE ACTIFLO INDWELLING BOWEL CATHETER SYSTEM. THE CONTRAINDICATIONS IN THE INSTRUCTIONS FOR USE STATE "DO NOT USE ON PTS WITH COMPROMISED RECTAL WALL INTEGRITY."
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS SUBSTANTIAL PT BLEEDING UPON INSERTION AND REMOVAL OF THE ACTIFLO INDWELLING BOWEL CATHETER SYSTEM. THE DIRECTOR OF NURSING STATED THAT RECTAL FISSURES WERE PRESENT IN THE PT PRIOR TO THE INSERTION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM | ACTIFLO RECTAL CATHETER | KNT | HOLLISTER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |