MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-05 for MOVEEN NIGHT BAG,2000/140 2134601400 manufactured by Coloplast A/s.
[177849725]
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.
Patient Sequence No: 1, Text Type: N, H10
[177849726]
According to the available information, during the night the urine flow stopped, which caused the urine to "back up into his bladder" and hereafter he got an uti, for which he was hospitalized for 8 days and received antibiotics. The patient is now home and recovering. It is unclear whether the tube of the urine bag, the mec or both were twisted and caused the blocked urine flow. The user describes that he is using the urine bag as described in the ifu, expect for washing it with bleach and water and re-using it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003814961-2020-00001 |
| MDR Report Key | 9672878 |
| Report Source | OTHER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-05 |
| 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 | MIKE BUMGARNER |
| Manufacturer Street | 1601 WEST RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122630488 |
| Manufacturer G1 | COLOPLAST A/S TATABANYA |
| Manufacturer Street | B?ZAVIR?G U. 15 |
| Manufacturer City | TATAB?NYA, 2800 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOVEEN NIGHT BAG,2000/140 |
| Generic Name | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE |
| Product Code | FAQ |
| Date Received | 2020-02-05 |
| Model Number | 2134601400 |
| Catalog Number | 2134601400 |
| 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 | 2020-02-05 |