MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2010-11-20 for CONVEEN OPTIMA 2203001004 manufactured by Coloplast A/s.
[1814314]
(b)(4). According to the information received, a complaint was filled by a lawyer who is the legal guardian to a (b)(6) severly disabled male patient. The patient used conveen optima and the adhesion was insufficient. Due to this he used additionally (b)(4), at the first application without any problems. At the 2nd application-at removal-the penile sheath skin was teared off at 4 sites (each with 4mm x 10mm) which resulted in severe bleeding.
Patient Sequence No: 1, Text Type: D, B5
[8975668]
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 commenting on the condition of the device or the cause of the occurence. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006606901-2010-00010 |
| MDR Report Key | 1903785 |
| Report Source | 01,04 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-10-29 |
| Date of Event | 2010-05-19 |
| Date Mfgr Received | 2010-10-29 |
| Date Added to Maude | 2010-11-22 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | COLOPLAST HUNGARY KFT COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR, HU 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 4300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVEEN OPTIMA |
| Generic Name | MALE EXTERNAL CATHETER-UROSHEATH |
| Product Code | EXJ |
| Date Received | 2010-11-20 |
| Model Number | 2203001004 |
| Catalog Number | 2203001004 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-20 |