MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-03-16 for ALPINE REUSABLE LEG BAG LATEX 32 OZ ST 5596001400 manufactured by Coloplast Manufacturing Us Llc.
[2540925]
(b)(4). According to the infomation received, a user reported a urine bag would not let his foley catheter drain. The user stated he needed to go to the hospital because of backflow of urine.
Patient Sequence No: 1, Text Type: D, B5
[9697189]
No samples were returned for evaluation. Without the benefit of analyzing the device, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. If additional information is received, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2012-00010 |
| MDR Report Key | 2494518 |
| Report Source | 04 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-02-16 |
| Date Mfgr Received | 2012-02-16 |
| Date Added to Maude | 2012-03-16 |
| 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 |
| 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 | 6123054987 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPINE REUSABLE LEG BAG LATEX 32 OZ ST |
| Generic Name | URINE BAG |
| Product Code | NNW |
| Date Received | 2012-03-16 |
| Model Number | 5596001400 |
| Catalog Number | 5596001400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US LLC |
| Manufacturer Address | 1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-03-16 |