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 |