MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-08-27 for FREEDOM URINE BAG W/TTAP DRN KIT 500 ML 5081301400 manufactured by Coloplast Manufacturing Us, Llc.
[19928749]
(b)(6). According to the information received, a urine bag was reported to have a flutter valve malfunction. The user found that the flutter valve becomes tangled and will block the flow of urine. Customer is using detergent and white vinegar to clean the bag. This problem happens after a couple weeks. Customer tries not to use the bag longer than two weeks. Customer states that this problem happens from time to time. Customer also finds that the white cap on the t-tap is popping off.
Patient Sequence No: 1, Text Type: D, B5
[20100948]
The product was not available to be returned. 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 | 2183558-2010-00033 |
| MDR Report Key | 1818733 |
| Report Source | 04 |
| Date Received | 2010-08-27 |
| Date of Report | 2010-07-23 |
| Date Mfgr Received | 2010-07-23 |
| Date Added to Maude | 2011-04-07 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM URINE BAG W/TTAP DRN KIT 500 ML |
| Generic Name | URINE BAG |
| Product Code | NNW |
| Date Received | 2010-08-27 |
| Model Number | 5081301400 |
| Catalog Number | 5081301400 |
| Lot Number | NA |
| Device Age | DA |
| 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 | 2010-08-27 |