MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-30 for MIO? manufactured by .
| Report Number | 3003442380-2019-01950 |
| MDR Report Key | 9392202 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-30 |
| Date Mfgr Received | 2019-11-01 |
| Date Added to Maude | 2019-11-30 |
| 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 Street | AAHOLMVEJ 1-3 OSTED |
| Manufacturer City | LEJRE, 4320 |
| Manufacturer Country | DA |
| Manufacturer Postal | 4320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIO? |
| Generic Name | INSET II 46/6 PCC BLUE |
| Product Code | FPA |
| Date Received | 2019-11-30 |
| Lot Number | 5259959 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-30 |