MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-03-23 for CONVEEN OPTIMA ?35 2203501001 manufactured by Coloplast A/s.
[70643004]
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, as no lot number is provided it is impossible to trace the relevant product documentation and check if similar faults were registered from the particular production lot. No additional complaints registered about this item no. Current month same issue. The complaints are monitored closely for a forming trend and reported to management on a monthly basis. Production has been informed. As no lot number is provided it is impossible to trace the relevant product documentation and check the ncrs.
Patient Sequence No: 1, Text Type: N, H10
[70643005]
According to the available information; patient experienced erosion, urinary infection. Antibiotics treatment (enterocystoplasties patient-usual infection).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2017-00009 |
| MDR Report Key | 6427380 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-22 |
| Date of Event | 2016-12-31 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-03-23 |
| 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 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 |
| Product Code | EXJ |
| Date Received | 2017-03-23 |
| Model Number | 2203501001 |
| Catalog Number | 2203501001 |
| 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, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-23 |