FDA Adverse Event
Injury
Summary report: N
ILEOSTOMY CATHETER
MDR report key: 5306590
·
Received December 17, 2015
Report
- Report Number
- 3009632672-2015-00014
- Event Type
- Injury
- Date Received
- December 17, 2015
- Report Date
- December 17, 2015
- Manufacturer
- WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
- Product Code
- KPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS NOT ABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. NO SAMPLES WERE RECEIVED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER THE ILEOSTOMY CATHETER IS TOO SOFT WHICH MAKES IT KINK UPON USAGE. THE KINKED CATHETER INDUCES PAIN AND BLEEDING. AS A RESULT OF THE PAIN AND BLEEDING REPORTED A REVISION SURGERY OF THE STOMA WILL BE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832664 | ILEOSTOMY CATHETER | CATHETER, RECTAL FOR CONTINENT ILEOSTOMY | KPH | WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB | 68730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |