FDA Adverse Event
Malfunction
Summary report: N
LONG SELF-CATH CH14
MDR report key: 1648232
·
Received April 1, 2010
Report
- Report Number
- 2183558-2010-00008
- Event Type
- Malfunction
- Date Received
- April 1, 2010
- Report Date
- March 15, 2010
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K003784
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
ONE CATHETER WAS RETURNED FOR EVALUATION. EXAMINATION OF THE CATHETER REVEALED THAT THE EYELETS HAD BEEN STAMPED ON THE OUTSIDE OF THE CATHETER BUT NOT PUNCHED THROUGH. THEREFORE, COLOPLAST CONFIRMED THE COMPLAINT AS REPORTED. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER. BASED ON THIS INFORMATION, COLOPLAST CONCLUDES THAT THIS IS AN ISOLATED INCIDENT AND DOES NOT REPRESENT THE OVERALL QUALITY OF THE LOT.
Description of Event or Problem · 1
(B)(6). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH MISSING EYELETS. ONE CATHETER HAD EYELETS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG SELF-CATH CH14 | INTERMITTENT CATHETER | KOD | COLOPLAST MANUFACTURING US, LLC | 5022101400 | 2255002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |