MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-19 for OSFERION DN-GM-KC manufactured by Olympus Terumo Biomaterials Corp. Mishima Factory.
| Report Number | 3007738819-2018-00015 |
| MDR Report Key | 9857965 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-19 |
| Date of Report | 2018-06-22 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JIRO HIRAI |
| Manufacturer Street | 1-50-1 SASAZUKA,SHIBUYA-KU |
| Manufacturer City | TOKYO, 151-0073 |
| Manufacturer Country | JA |
| Manufacturer Postal | 151-0073 |
| Manufacturer G1 | OLYMPUS TERUMO BIOMATERIALS CORP. |
| Manufacturer Street | 1-50-1 SASAZUKA,SHIBUYA-KU |
| Manufacturer City | TOKYO, 151-0073 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 151-0073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSFERION |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2020-03-19 |
| Catalog Number | DN-GM-KC |
| Lot Number | M16Y01C251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY |
| Manufacturer Address | 454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |