D
Patient 1
DATE OF EVENT: (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, A USER EXPERIENCED IRRITATION AND BLEEDING SKIN AFTER USING A URISHEATH. THE USER APPLIED CREAM TO THE WOUND TO HELP IT HEAL.
MAUDE MDR 2822177
- MDR report key
- 2822177
- Report number
- 3006606901-2012-00010
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-03-16
- Date received
- 2012-04-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR BRIAN SCHMIDT
- Address
- 1601 W. RIVER RD., NORTH MINNEAPOLIS MN 55411 US
- Phone
- 612-612-6122
- 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 25 | MALE EXTERNAL CATHETER-UROSHEATH | COLOPLAST A/S | EXJ | 2202501001 | 2202501001 | 3069440 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-04-26 | 0 | 1. O |
Event Narratives#
N
Patient 1
ONE PRODUCT WAS RETURNED FOR EVALUATION. A PEEL TEST WAS PERFORMED ON THE DEVICE AND WAS WITHIN THE SPECIFICATION. SEEING THAT THE RETURNED PRODUCT PERFORMED ACCORDING TO DEVICE SPECIFICATIONS THIS COMPLAINT CANNOT BE CONFIRMED AS REPORTED.