MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-10-04 for MICROAIRE SURGICAL INSTRUMENTS 6130 * manufactured by Microaire Surgical Instruments.
[15037507]
Microaire customer service was contacted by microaire rep claiming that a microaire loaner instrument overheated during use at a customer facility. It was reported that the high-speed drill overheated during a molar extraction procedure causing the pt to allegedly suffer a "2nd" degree burn on their lower lip and an area just below the lip. The customer contact stated that the burn covered approximately one square inch on and below the pt right lower lip. The customer contact also stated that the dr treated the pt with "creams", and that the pt has been returning to the customer facility on a weekly basis for follow-up visits related to the alleged burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020601-2002-00003 |
| MDR Report Key | 420742 |
| Report Source | 07 |
| Date Received | 2002-10-04 |
| Date of Report | 2002-10-04 |
| Date of Event | 2002-08-30 |
| Date Mfgr Received | 2002-09-04 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2002-10-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CARL ANGLES |
| Manufacturer Street | 1641 EDLICH DR |
| Manufacturer City | CHARLOTTESVILLE VA 22911 |
| Manufacturer Country | US |
| Manufacturer Postal | 22911 |
| Manufacturer Phone | 4349758000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROAIRE SURGICAL INSTRUMENTS |
| Generic Name | HIGH SPEED DRILL |
| Product Code | DWI |
| Date Received | 2002-10-04 |
| Model Number | 6130 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 409788 |
| 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. Required No Informationntervention | 2002-10-04 |