MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for OSTEOPOWER 450-0241 manufactured by Osteomed.
| Report Number | 2027754-2019-00014 |
| MDR Report Key | 9119485 |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-09-25 |
| 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 | MRS. LATOIA PHILLIPS |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer G1 | OSTEOMED |
| Manufacturer Street | 3885 ARAPAHO RD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSTEOPOWER |
| Generic Name | RECIPROCATING SAW, QUICK RELEASE |
| Product Code | KMW |
| Date Received | 2019-09-25 |
| Catalog Number | 450-0241 |
| Lot Number | 1014710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-25 |