D
Patient 1
ACCORDING TO THE INFO RECEIVED, A USER REPORTED THAT A MALE EXTERNAL CATHETER GAVE HIM AN INFECTION. THE ADHESIVE WAS SO STRONG, THAT THE REMOVAL PROCESS WAS DIFFICULT AND PEELED OFF HIS SKIN.
MAUDE MDR 2822287
- MDR report key
- 2822287
- Report number
- 3006606901-2012-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-02-01
- Date received
- 2012-05-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. BRIAN SCHMIDT
- Address
- 1601 W. RIVER ROAD N. MINNEAPOLIS MN 55411 US
- Phone
- 612-612-6123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CONVEEN OPTIMA | MALE EXTERNAL CATHETER-UROSHEATH | COLOPLAST A/S | EXJ | 2203001400 | 2203001400 | 3063776 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-05-29 | 0 | 1. O |
Event Narratives#
N
Patient 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 COMMENCING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. F/U 1: 3 DEVICES WERE RETURNED FOR EVAL. ALL OF THE MEASURED VALUES WERE WITHIN SPECIFICATION. BASED UPON THE PERFORMANCE TESTING, THIS COMPLAINT CANNOT BE CONFIRMED AS REPORTED.