MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-11-11 for CYSTOCARE GOLD UB04201002 manufactured by Coloplast Manufacturing Us, Llc.
[18179525]
(b)(6). According to the information received, during a operation for the resection of a bladder tumor, a leg collapsed (first using). This resulted in a blocked catheter so there was urinary retention and clot formation. The bag was changed and no product was kept.
Patient Sequence No: 1, Text Type: D, B5
[18205741]
Information received indicated there are no samples to return for evaluation. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence. Should the device or additional information be received, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183558-2010-00046 |
| MDR Report Key | 1896936 |
| Report Source | 01,05 |
| Date Received | 2010-11-11 |
| Date of Report | 2010-04-13 |
| Date Mfgr Received | 2010-04-13 |
| Date Added to Maude | 2010-11-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. 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 MANUFACTURING US, LLC |
| Manufacturer Street | 1185 WILLOW LAKE BLVD |
| Manufacturer City | VADNAIS HEIGHTS, MN 55110 55110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55110 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOCARE GOLD |
| Generic Name | URINE LEG BAG |
| Product Code | NNW |
| Date Received | 2010-11-11 |
| Model Number | UB04201002 |
| Catalog Number | UB04201002 |
| Lot Number | 1507517 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | 1185 WILLOW LAKE BLVD. VADNAIS HEIGHTS MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-11 |