MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-02 for AESCULAP GB130R * manufactured by Aesculap, Inc..
[16735034]
A patient underwent a le fort 1 osteotomy. During the completion of the osteotomy, the protected portion of the handpiece made contact with the extra oral portion of the left upper lip. According to the surgeon, this portion of the handpiece was warm. The surgeon finished the procedure without any complications. During the post operative period, the lip was noted to have a superficial second degree burn which was treated with local wound care. The device heated up shortly into the procedure. Is event health it related? No
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832977 |
| MDR Report Key | 1832977 |
| Date Received | 2010-09-02 |
| Date of Report | 2010-08-31 |
| Date of Event | 2010-07-16 |
| Report Date | 2010-08-31 |
| Date Reported to FDA | 2010-09-02 |
| Date Added to Maude | 2010-09-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AESCULAP |
| Generic Name | RECIPROCATING SAW HAND PIECE |
| Product Code | HSO |
| Date Received | 2010-09-02 |
| Returned To Mfg | 2010-08-04 |
| Model Number | GB130R |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-02 |