MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for CONVEEN OPTIMA ?35 2203501001 manufactured by Coloplast A/s.
[57251039]
No additional complaints registered about this lot number. No additional complaints registered about this item no. Current month same issue. Complaints such as this is a new issue with this product line. The complaints are monitored closely for a forming trend and reported to management on a monthly basis. A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[57251040]
According to the information received, the patient was not a first time user and had used the urisheath for about 45 days with conveen active. He changed the product every day and cleaned his skin with water and soap. Skin irritation was observed after 30 days of use. There was redness, skin blister on each side of the penis where veins were visible and a little under. There was pain (itching and burning sensation) at the base of the penis where the urisheath stopped. The patient saw a doctor who prescribed a cream (pomade) named biafine 3 times a day. The skin irritation was a little better and the patient switched to another brand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2016-00036 |
| MDR Report Key | 6024632 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-10-12 |
| Date Mfgr Received | 2016-09-14 |
| Date Added to Maude | 2016-10-12 |
| 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 ?35 |
| Generic Name | MALE EXTERNAL CATHETER-UROSHEATH |
| Product Code | EXJ |
| Date Received | 2016-10-12 |
| Returned To Mfg | 2016-10-05 |
| Model Number | 2203501001 |
| Catalog Number | 2203501001 |
| Lot Number | 5250912 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-10-12 |