MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-07-08 for HALL SURGICAL BUR GUARD 00-1375-012-00 manufactured by Linvatec Corp..
[141769]
Surgeon reported the bur guard to be 'loose' which resulted in a 'small tear' on the patient's lip. No medical intervention required except the application of antibiotic ointment. The scrub nurse reported that there was 'no play in the bur guard. ' patient was seen by a plastic surgeon. No surgical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-1999-00025 |
| MDR Report Key | 231545 |
| Report Source | 05,06 |
| Date Received | 1999-07-08 |
| Date of Report | 1999-06-08 |
| Date of Event | 1999-06-07 |
| Report Date | 1999-07-07 |
| Date Mfgr Received | 1999-06-08 |
| Device Manufacturer Date | 1994-06-01 |
| Date Added to Maude | 1999-07-15 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL SURGICAL BUR GUARD |
| Generic Name | BUR GUARD |
| Product Code | HXY |
| Date Received | 1999-07-08 |
| Returned To Mfg | 1999-06-16 |
| Model Number | NA |
| Catalog Number | 00-1375-012-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 224442 |
| Manufacturer | LINVATEC CORP. |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-07-08 |