MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for MICROAIRE BUR ZB-104 manufactured by Microaire Surgical Instruments.
| Report Number | 2020601-2019-00005 |
| MDR Report Key | 8756126 |
| Date Received | 2019-07-02 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-04 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2019-07-02 |
| 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 | MR. BRIAN AMELL |
| Manufacturer Street | 3590 GRAND FORKS BOULEVARD |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349758394 |
| Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Street | 3590 GRAND FORKS BOULEVARD |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROAIRE BUR |
| Generic Name | CARBIDE BUR, SIDE CUTTING |
| Product Code | GFF |
| Date Received | 2019-07-02 |
| Model Number | ZB-104 |
| Catalog Number | ZB-104 |
| Lot Number | 0617309582 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS |
| Manufacturer Address | 3590 GRAND FORKS BLVD. CHARLOTTESVILLE VA 22911 US 22911 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-02 |