FDA Adverse Event
Injury
Summary report: N
FREEDOM SELF CATH PLUS FEMALE CH14
MDR report key: 1890182
·
Received November 3, 2010
Report
- Report Number
- 2183558-2010-00041
- Event Type
- Injury
- Date Received
- November 3, 2010
- Report Date
- October 11, 2010
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K003784
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
QA INSPECTED THE SAMPLE AND FOUND THROUGH EXAMINATION THAT THE ONE EYELET HAD BEEN STAMPED ONTO THE CATHETER, BUT WASN'T PUNCHED ALL THE WAY THROUGH AND THE SECOND EYELET WASN'T VISIBLE AT ALL. THEREFORE, THE COMPLAINT IS CONFIRMED AS REPORTED. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER. BASED ON THIS INFORMATION, QA 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, A CATHETER HAD MISSING EYELETS. A USER STATED THAT THE CATH DID NOT DRAIN HER URINE WHEN INSERTED. THE CATHETER WAS MISSING THE EYELETS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM SELF CATH PLUS FEMALE CH14 | INTERMITTENT CATHETER | KOD | COLOPLAST MANUFACTURING US, LLC | 5050401400 | 2252272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |