MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-11-16 for CONVEEN OPTIMA SHORT ?30 2213001004 manufactured by Coloplast A/s.
[60023753]
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
[60023754]
According to the available information, the end user uses urisheaths since more than 10 years. He never had problems with usage before. The urisheaths were put on by the nurse. He wears an urisheath 8-10 hours per day. Accessories like adhesive remover wipes or spray were used but only if there are black pieces (perhaps textile fibres? ) of adhesive on the skin. Two days before the skin got coloured blue-red at three areas between prepuce and glans. He consulted a dermatologist and a urologist on (b)(6) 2016. The urologist advised him to wear the urisheaths only some minutes for the time when he wants to urinate. He has much pain that radiates in the testicles while passing urine and the urine stream is thinner than usually. He says that he has used zinc cream and his outcome is much better now. The skin has healed almost completely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2016-00042 |
| MDR Report Key | 6106495 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-11-16 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-11-11 |
| Date Added to Maude | 2016-11-16 |
| 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 | 3 |
| Brand Name | CONVEEN OPTIMA SHORT ?30 |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2016-11-16 |
| Model Number | 2213001004 |
| Catalog Number | 2213001004 |
| Lot Number | 4955906 |
| Operator | NURSE |
| 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 | 2016-11-16 |