FDA Adverse Event
Malfunction
Summary report: N
FREEDOM SELF-CATH PLUS CH14
MDR report key: 1585191
·
Received January 25, 2010
Report
- Report Number
- 2183558-2010-00002
- Event Type
- Malfunction
- Date Received
- January 25, 2010
- Report Date
- January 4, 2010
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- EYB
- PMA / PMN Number
- K003784
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE RETURN OF THE DEVICE HAS BEEN REQUESTED; HOWEVER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
(B)(6). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CUTOFF CATHETER. THE END USER STATED "CATHETERS HAVE BEEN CUT SO LOW THAT YOU CAN NOT PUT WATER IN THEM, CATHS CUT IN HALF".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM SELF-CATH PLUS CH14 | INTERMITTENT CATHETER | EYB | COLOPLAST MANUFACTURING US, LLC | 5049301400 | 2222474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |