MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-06 for MIO 1P LIGHT URO MX TRP10-23 1683501400 manufactured by Coloplast A/s.
[144167709]
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
[144167710]
According to the available information, the patient was using 16837 since (b)(6) 2017. The hospital switched them to 16835 in (b)(6) 2019. The patient stated that ever since jan 1st. The skin became raw and an infection on the stoma occurred. A lot number was not available. The patient has been in the hospital since friday (b)(6) 2019. Stoma was black and green. The hospital is giving her antibiotics. They switched to 16837 and cut it in oval shape and it seems to be doing better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003814961-2019-00001 |
| MDR Report Key | 8582989 |
| Report Source | OTHER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-07-01 |
| Date Mfgr Received | 2019-06-21 |
| Date Added to Maude | 2019-05-06 |
| 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 | 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 HUNGARY KFT TATABANYA |
| Manufacturer Street | BUZAVIRAG UT 15 KOMAROM-ESZTERGOM |
| Manufacturer City | TATABANYA, 2800 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIO 1P LIGHT URO MX TRP10-23 |
| Generic Name | COLLECTOR, OSTOMY |
| Product Code | EXB |
| Date Received | 2019-05-06 |
| Model Number | 1683501400 |
| Catalog Number | 1683501400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-06 |