FDA Adverse Event
Malfunction
Summary report: N
LONG SELF-CATH CH12
MDR report key: 1617523
·
Received March 1, 2010
Report
- Report Number
- 2183558-2010-00005
- Event Type
- Malfunction
- Date Received
- March 1, 2010
- Report Date
- February 3, 2010
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- EYB
- PMA / PMN Number
- K003784
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST 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.
Description of Event or Problem · 1
(B)(6). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH A TIP CUT OFF/OPEN/BROKEN. THE CATHETER HAD THE TIP CUT OFF AND WAS MISPACKAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG SELF-CATH CH12 | INTERMITTENT CATHETER | EYB | COLOPLAST MANUFACTURING US, LLC | 5022001400 | 1809398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |