MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-06-07 for HALL SURGICAL BUR GUARD 00137501200 manufactured by Conmed Linvatec Corp.
[596802]
The customer reported that during use, the device got hot. It was reported that the pt received about "a nickel-size burn" on the inside lower lip and that the surgeon treated the burn successfully with vaseline.
Patient Sequence No: 1, Text Type: D, B5
[7938533]
Investigation findings: the customer's report of getting hot was not confirmed. The bur guard was evaluated and met normal temperature specifications. Further examination found foreign material on the exterior and interior of the device. Conmed linvatec repair records found no service date for this bur guard. The recommended preventative maintenance is every six months. The customer will be contacted for any add'l inservicing needs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00183 |
| MDR Report Key | 803055 |
| Report Source | 05,07 |
| Date Received | 2006-06-07 |
| Date of Report | 2006-05-08 |
| Date of Event | 2006-05-01 |
| Date Mfgr Received | 2006-05-08 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2007-01-12 |
| 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 | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC CORP |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| 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 | 2006-06-07 |
| Returned To Mfg | 2006-05-18 |
| Model Number | NA |
| Catalog Number | 00137501200 |
| Lot Number | AUG05 |
| ID Number | NA |
| 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 | 790559 |
| Manufacturer | CONMED LINVATEC CORP |
| Manufacturer Address | * LARGO FL * 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 | 505800100 | 1. Other | 2006-06-07 |