MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for CONVEEN OPTIMA ?30 2203001004 manufactured by Coloplast A/s.
[35006042]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence, should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[35006043]
According to the information received, the skin under the whole urisheath is red and aching, skin looks like peeled.... Enduser removes the adhesive with warm water. No signs of infection. He uses incontinence pads when the redness appeared. With the incontinence pads the redness disappeared after 2 days but when he uses urisheaths again redness and aching returned. Skin is already red (complete area), he will continue as usual: if skin is red he uses incontinence pads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2015-00029 |
| MDR Report Key | 5342176 |
| Date Received | 2016-01-04 |
| Date of Report | 2016-01-04 |
| Date Mfgr Received | 2015-12-10 |
| Date Added to Maude | 2016-01-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE BUCKVOLD |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024982 |
| Manufacturer G1 | COLOPLAST A/S NYIRBATOR |
| Manufacturer Street | COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR, 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 4300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONVEEN OPTIMA ?30 |
| Generic Name | MALE EXTERNAL CATHETER, UROSHEATH |
| Product Code | EXJ |
| Date Received | 2016-01-04 |
| Model Number | 2203001004 |
| Catalog Number | 2203001004 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-04 |