FDA Adverse Event
Malfunction
Summary report: N
LONG SELF-CATH CH14
MDR report key: 1360790
·
Received March 3, 2009
Report
- Report Number
- 2183558-2009-00014
- Event Type
- Malfunction
- Date Received
- March 3, 2009
- Date of Event
- February 1, 2009
- Report Date
- February 3, 2009
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K003873
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURN OF THE DEVICE HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. NO LOT NUMBER WAS AVAILABLE TO CONDUCT A REVIEW OF THE LOT HISTORY RECORDS. 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 ADD'L INFO BE RECEIVED, FOLLOW-UP REPORT WILL BE FILED. NO OTHER COMPLAINTS HAVE BEEN RECORDED TO DATE FOR THIS LOT NUMBER.
Description of Event or Problem · 1
A DISTRIBUTOR REPORTED ON BEHALF OF A USER & PHYSICIAN THAT A CATHETER WAS RECEIVED IN WHICH THE GREEN FUNNEL WAS PLACED ON THE WRONG END. THE END THAT IS INSERTED INTO THE URETHRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG SELF-CATH CH14 | INTERMITTENT CATHETER | KOD | COLOPLAST MANUFACTURING US, LLC | 5022101400 | 1623411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |