MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-02 for MICRO AINE 2910-011 manufactured by Microaire Surgical Inst..
[35733]
Reported that burguard nose bearing came out during surgery in pt's mouth. No injury to pt was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020601-1996-00157 |
| MDR Report Key | 55068 |
| Report Source | 05 |
| Date Received | 1996-10-02 |
| Date of Report | 1996-10-01 |
| Date of Event | 1996-09-03 |
| Date Mfgr Received | 1996-09-03 |
| Date Added to Maude | 1996-12-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO AINE |
| Generic Name | BURR GUARD |
| Product Code | HXY |
| Date Received | 1996-10-02 |
| Returned To Mfg | 1996-09-04 |
| Model Number | 2910-011 |
| Catalog Number | 2910-011 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55614 |
| Manufacturer | MICROAIRE SURGICAL INST. |
| Manufacturer Address | 1641 EDLICH DR CHARLOTTESVILLE VA 22911 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-02 |