FDA Adverse Event
Injury
Summary report: N
SELF CATH FEMALE W/LUER END 14FR
MDR report key: 3231900
·
Received December 11, 2012
Report
- Report Number
- 3005945907-2012-00032
- Event Type
- Injury
- Date Received
- December 11, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- COLOPLAST A/S
- Product Code
- KOD
- PMA / PMN Number
- K100878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 OCCURRENCE. SHOULD THE DEVICE OR ADD'L INFO BE REC'D, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
ACCORDING TO THE INFO REC'D AN INDIVIDUAL REPORTED THAT A PT WAS CURRENTLY HAVING SURGERY DUE TO BLOOD CLOTS IN THE BLADDER FROM THE CATHETERS CUTTING/SCRATCHING THE PT. MEDICAL HISTORY IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELF CATH FEMALE W/LUER END 14FR | INTERMITTENT CATHETER | KOD | COLOPLAST A/S | 5019601400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |