FDA Adverse Event
Injury
Summary report: N
CONVEEN COUNTOUR, 800/45
MDR report key: 1890041
·
Received November 3, 2010
Report
- Report Number
- 9610694-2010-00014
- Event Type
- Injury
- Date Received
- November 3, 2010
- Report Date
- August 2, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- FAQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
URINE BAG SAMPLES WERE RECEIVED AND TESTED. TESTING DID NOT PROVIDE AN EXPLANATION AS TO WHAT MAY HAVE CAUSED THE PROBLEM IN THIS REPORT AS THE FAILURE COULD NOT BE DUPLICATED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
(B)(6). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A URINE BAG WITH BLOCKED URINEFLOW. THE URINE GOES OUT OF THE CATHETER AND INTO THE TUBING BUT ONCE IT GETS TO THE BAG IT DOESN'T GO DOWN INTO THE BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONVEEN COUNTOUR, 800/45 | URINE BAGE | FAQ | COLOPLAST A/S | 0517401400 | 2404662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |