FDA Adverse Event
Malfunction
Summary report: N
SPEEDICATH CH10 MALE
MDR report key: 2143414
·
Received June 29, 2011
Report
- Report Number
- 3006606901-2011-00022
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Report Date
- May 20, 2011
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K023254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS AVAILABLE FOR TESTING. 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 ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
(B)(4).ACCORDING TO THE INFORMATION RECEIVED, FIVE 12FR CATHETERS WERE FOUND IN A BOX LABELED 10FR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDICATH CH10 MALE | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 2851001001 | 2620109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |