MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for CONVEEN CONTOUR,600/45 0517001732 manufactured by Coloplast A/s.
[37717482]
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. A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[37717483]
Blocked urineflow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610694-2016-00001 |
| MDR Report Key | 5402608 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-02-01 |
| Date Mfgr Received | 2016-01-08 |
| Date Added to Maude | 2016-02-01 |
| 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 |
| Manufacturer Street | HOLTEDAM 1 |
| Manufacturer City | HUMLEBAEK, DA 3050 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 3050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONVEEN CONTOUR,600/45 |
| Generic Name | URINE BAG |
| Product Code | FAQ |
| Date Received | 2016-02-01 |
| Model Number | 0517001732 |
| Catalog Number | 0517001732 |
| Lot Number | 4795587 |
| 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, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-01 |