MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-04-26 for CONVEEN OPTIMA 25 2202501001 manufactured by Coloplast A/s.
[17462316]
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.
Patient Sequence No: 1, Text Type: D, B5
[17647536]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006606901-2012-00010 |
| MDR Report Key | 2822177 |
| Report Source | 01,05 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-16 |
| Date Mfgr Received | 2012-03-29 |
| Device Manufacturer Date | 2011-11-15 |
| Date Added to Maude | 2012-11-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR BRIAN SCHMIDT |
| Manufacturer Street | 1601 W. RIVER RD., NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122874138 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR HU 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | HU 4300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVEEN OPTIMA 25 |
| Generic Name | MALE EXTERNAL CATHETER-UROSHEATH |
| Product Code | EXJ |
| Date Received | 2012-04-26 |
| Model Number | 2202501001 |
| Catalog Number | 2202501001 |
| Lot Number | 3069440 |
| Device Expiration Date | 2016-11-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK, DA 3050 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-26 |