MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-05-29 for CONVEEN OPTIMA 2203001400 manufactured by Coloplast A/s.
[20645824]
According to the info received, a user reported that a male external catheter gave him an infection. The adhesive was so strong, that the removal process was difficult and peeled off his skin.
Patient Sequence No: 1, Text Type: D, B5
[20910289]
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 commencing on the condition of the device or the cause of the occurrence. Should additional info become available a f/u report will be submitted. F/u 1: 3 devices were returned for eval. All of the measured values were within specification. Based upon the performance testing, this complaint cannot be confirmed as reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006606901-2012-00011 |
| MDR Report Key | 2822287 |
| Report Source | 04 |
| Date Received | 2012-05-29 |
| Date of Report | 2012-02-09 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-02-09 |
| Device Manufacturer Date | 2012-11-09 |
| Date Added to Maude | 2012-11-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRIAN SCHMIDT |
| Manufacturer Street | 1601 W. RIVER ROAD N. |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR 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 | 2012-05-29 |
| Model Number | 2203001400 |
| Catalog Number | 2203001400 |
| Lot Number | 3063776 |
| Device Expiration Date | 2016-11-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-29 |