MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-12 for MOVEEN NIGHT BAG,2000/140 2135601400 manufactured by Coloplast A/s.
[126922486]
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
[126922487]
According to the available information, the end user had a bladder infection which was not treatable with normal antibiotics. A picc line had to be administered and a concoction of medicine was infused for seven days. Per notes, end user is currently using competitor foley from poieses duette indwelling catheters with our 21356 moveen drainage bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003814961-2018-00001 |
| MDR Report Key | 8061725 |
| Date Received | 2018-11-12 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-11-12 |
| 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 |
| Manufacturer City | TATAB 2800 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MOVEEN NIGHT BAG,2000/140 |
| Generic Name | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE |
| Product Code | FAQ |
| Date Received | 2018-11-12 |
| Model Number | 2135601400 |
| Catalog Number | 2135601400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, REGION HOVEDSTADEN 3050 DA 3050 |
| Brand Name | MOVEEN NIGHT BAG,2000/140 |
| Generic Name | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE |
| Product Code | FAQ |
| Date Received | 2018-11-12 |
| Model Number | 2135601400 |
| Catalog Number | 2135601400 |
| 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, REGION HOVEDSTADEN 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-12 |