MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2016-09-21 for CONVEEN OPTIMA ?30 2203001004 manufactured by Coloplast A/s.
[55258920]
As we have no received back any samples yet, the necessary tests cannot be made. 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. However, a recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint. 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. Production has been informed.
Patient Sequence No: 1, Text Type: N, H10
[55258921]
The user has sent a photo by email to the distributor and stated he fears he has got urinary tract infection caused by optima urisheaths, as he has found strange residue/deposit in the sheath. The urisheath on the photo is not used. The user actually is on holidays, so we cannot ask him whether he has consulted a doctor or if he takes medicine to treat the infection. The distributor will ask him about his outcome and the treatment as soon as the user returned from holidays. The enduser is still on holidays and unfortunately he does not know when he will be back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2016-00035 |
| MDR Report Key | 5966699 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-21 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-21 |
| 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 ?30 |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2016-09-21 |
| Model Number | 2203001004 |
| Catalog Number | 2203001004 |
| Lot Number | 5250986 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-09-21 |