FDA Adverse Event
Injury
Summary report: N
LONG SELF-CATH CH14
MDR report key: 2370081
·
Received May 6, 2010
Report
- Report Number
- 2183558-2010-00018
- Event Type
- Injury
- Date Received
- May 6, 2010
- Date of Event
- January 1, 2008
- Report Date
- January 15, 2008
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K003784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH NO EYELETS WHICH WOULD NOT LET URINE FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG SELF-CATH CH14 | INTERMITTENT CATHETER, PRODUCT CODE: KOD | KOD | COLOPLAST MANUFACTURING US, LLC | 5022101400 | 5719454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |