FDA Adverse Event
Injury
Summary report: N
FREEDOM SELF-CATH FEMALE CH10
MDR report key: 1645781
·
Received March 30, 2010
Report
- Report Number
- 2183558-2010-00007
- Event Type
- Injury
- Date Received
- March 30, 2010
- Report Date
- March 2, 2010
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- KOD
- PMA / PMN Number
- K003784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
(B) (4), DATE OF EVENT: BEST ESTIMATE IS (B) (6) 2010. ACCORDING TO THE INFORMATION RECEIVED, A CATHETER WAS DAMAGED OR BROKEN. THE FUNNEL CAME OFF OF THE CATHETER CAUSING THE CUSTOMER TO GO TO THE ER AT THE HOSPITAL TO HAVE THE CATHETER REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM SELF-CATH FEMALE CH10 | INTERMITTENT CATHETER | KOD | COLOPLAST MANUFACTURING US, LLC | 5046101400 | 2126449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |