FDA Adverse Event
Malfunction
Summary report: N
SELF CATH LONG CURVED PACKAGE 14FR
MDR report key: 2040287
·
Received April 5, 2011
Report
- Report Number
- 2183558-2011-00014
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Report Date
- March 10, 2011
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K100878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
ONE CATHETER WAS RECEIVED FOR EVALUATION. EXAMINATION AND INSPECTION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER WAS MISSING A TIP. THEREFORE THE COMPLAINT CAN BE CONFIRMED AS REPORTED.
Description of Event or Problem · 1
DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED, A CATHETER IS MISSING A TIP. THE BOTTOM HALF OF THE CATHETER IS PRESENT WITH THE FUNNEL AT THE END BUT THERE IS NO TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELF CATH LONG CURVED PACKAGE 14FR | INTERMITTENT CATHETER | KOD | COLOPLAST MANUFACTURING US, LLC | 5022101400 | 2636000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |