MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for OSSIX PLUS manufactured by Datum Dental.
| Report Number | 3009443653-2017-00001 |
| MDR Report Key | 6230432 |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-10-17 |
| Date Facility Aware | 2016-12-09 |
| Report Date | 2017-01-06 |
| Date Reported to FDA | 2017-01-06 |
| Date Reported to Mfgr | 2017-01-06 |
| Date Added to Maude | 2017-01-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer City | LOD 7120101 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7120101 |
| Manufacturer G1 | DATUM DENTAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSSIX PLUS |
| Generic Name | BARRIER, ANIMAL SOURCE, INTRAORAL |
| Product Code | NPL |
| Date Received | 2017-01-06 |
| Model Number | OSSIX PLUS |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL |
| Manufacturer Address | LOD 7120101 IS 7120101 |