FDA Adverse Event
Malfunction
Summary report: N
SPEEDICATH COMPLETE CH14 MALE UK
MDR report key: 1910171
·
Received November 30, 2010
Report
- Report Number
- 3006606901-2010-00012
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Report Date
- July 19, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K023254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FOUR SAMPLES WERE RETURNED AND A VISUAL TEST WAS PERFORMED. IT WAS DETERMINED THAT THE EYELETS ON THE CATHETER WERE NOT BLOCKED. TESTING ON THE RETURNED CATHETERS DID NOT PROVIDE ANY EXPLANATION AS TO THE CAUSE OF THE REPORTED INCIDENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
(B)(4). ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A CATHETER/URINE BAG IN WHICH URINE WAS NOT GOING INTO THE BAG. IT WAS COMING BACK ON ITSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDICATH COMPLETE CH14 MALE UK | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 2846401006 | 2417174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |