FDA Adverse Event
Other
Summary report: N
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM
MDR report key: 2101187
·
Received May 19, 2011
Report
- Report Number
- 1480288-2011-00004
- Event Type
- Other
- Date Received
- May 19, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- HOLLISTER, INC.
- Product Code
- KNT
- PMA / PMN Number
- K083153
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A 4-5 CM LONG X 2-3 CM WIDE, SUPERIOR, FULL THICKNESS SKIN INJURY FOLLOWING THE USE OF THE ACTIFLO INDWELLING BOWEL CATHETER SYSTEM. THE MECHANISM OF INJURY WAS NOT DETERMINED. THE INJURY WAS NOT CIRCUMFERENTIAL BUT DIRECTIONAL, SUPERIORLY. NO TREATMENT WAS GIVEN DUE TO THE EXTENT OF STOOLING BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM | ACTIFLO RECTAL CATHETER | KNT | HOLLISTER, INC. | 32004 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |