MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-08-12 for MICROAIRE 6130 * manufactured by Microaire Surgical Instruments.
[361835]
Microaire received a report that a pt received an unspecified burn in the mouth area, during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020601-2004-00003 |
| MDR Report Key | 539115 |
| Report Source | 05,06 |
| Date Received | 2004-08-12 |
| Date of Report | 2004-08-11 |
| Date of Event | 2004-07-12 |
| Date Mfgr Received | 2004-07-20 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2004-08-17 |
| 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 | 0 |
| Manufacturer Contact | TODD MOORE |
| Manufacturer Street | 1641 EDLICH DR. |
| Manufacturer City | CHARLOTTESVILLE VA 22911 |
| Manufacturer Country | US |
| Manufacturer Postal | 22911 |
| Manufacturer Phone | 4349758336 |
| Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS |
| Manufacturer Street | 1641 EDLICH DR. |
| Manufacturer City | CHARLOTTESVILLE VA 22911 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22911 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROAIRE |
| Generic Name | HIGH SPEED DRILL |
| Product Code | DWI |
| Date Received | 2004-08-12 |
| Returned To Mfg | 2004-07-22 |
| Model Number | 6130 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 528410 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS |
| Manufacturer Address | 1641 EDLICH DR. CHARLOTTESVILLE VA 22911 US |
| Baseline Brand Name | MICROAIRE |
| Baseline Generic Name | HIGH-SPEED DRILL |
| Baseline Model No | 6130 |
| Baseline Catalog No | 6130 |
| Baseline ID | NA |
| Baseline Device Family | DRILL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955591 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-12 |