MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-10 for HALL SURGICAL BUR GUARD, MEDIUM 00137501200 manufactured by Linvatec Corporation.
[204351]
During impacted wisdom teeth removal bur guard overheated causing a burn to right lower commissure of pt's lip, approximately 1x2 cm. The area was treated with ointment. The pt has been examined post operatively and the area has healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-1999-00048 |
| MDR Report Key | 250333 |
| Report Source | 05,06 |
| Date Received | 1999-11-10 |
| Date of Report | 1999-10-13 |
| Date of Event | 1999-09-28 |
| Date Mfgr Received | 1999-10-13 |
| Date Added to Maude | 1999-11-22 |
| 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 | ROGER MURPHY |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995205 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL SURGICAL BUR GUARD, MEDIUM |
| Generic Name | BUR GUARD |
| Product Code | HXY |
| Date Received | 1999-11-10 |
| Returned To Mfg | 1999-10-12 |
| Model Number | NA |
| Catalog Number | 00137501200 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 242524 |
| Manufacturer | LINVATEC CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US |
| Baseline Brand Name | HALL SURGICAL BUR GUARD, MEDIUM |
| Baseline Generic Name | BUR GUARD |
| Baseline Model No | NA |
| Baseline Catalog No | 00137501200 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-10 |