FDA Adverse Event
Injury
Summary report: N
SELF CATH SOFT STRAIGHT TIP 14 FR
MDR report key: 2040264
·
Received April 5, 2011
Report
- Report Number
- 3005945907-2011-00010
- Event Type
- Injury
- Date Received
- April 5, 2011
- Report Date
- March 9, 2011
- Manufacturer
- COLOPLAST A/S
- Product Code
- KOD
- PMA / PMN Number
- K100878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
(B)(6), DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED THE USER STATED THAT THE EYELETS IN THE PAST COUPLE BOXES OF CATHETERS ARE SHARP AND NOT SMOOTH. THE USER IS REPORTING THAT THEY ARE CAUSING SOME PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELF CATH SOFT STRAIGHT TIP 14 FR | INTERMITTENT CATHETER | KOD | COLOPLAST A/S | 5018201400 | 2407296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |