MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-09-29 for CONVEEN OPTIMA 35 2203501017 manufactured by Coloplast A/s.
[27106311]
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 or 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
[27106312]
According to the information received, when the patient tried "conveen optima" for the first time, he did not seem to have a problem with the adhesivity of the product. He tried 22030 but finally opted for 22035 because he found the 22030 too tight. When he tried to remove the urisheath, it was impossible to do so. The doctor had to come to remove the uristheath with scissors and a pincet. Unfortunately, the urisheath was stuck so much that the skin came off. This happened on (b)(6). Today the patient is not using the urisheaths anymore trying to let his skin heal. An appointment with the rep was made, unfortunately, it was cancelled by the patient's son because the patient was terminal - no further information regarding this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2015-00017 |
| MDR Report Key | 5112333 |
| Report Source | FOREIGN |
| Date Received | 2015-09-29 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-08-19 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2015-07-10 |
| Date Added to Maude | 2015-09-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 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 35 |
| Generic Name | MALE EXTERNAL CATHETER-UROSHEATH |
| Product Code | EXJ |
| Date Received | 2015-09-29 |
| Model Number | 2203501017 |
| Catalog Number | 2203501017 |
| Lot Number | 4722179 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-09-29 |