MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-23 for BUR OVAL BUR 277-10-62 manufactured by Stryker.
[4613589]
Bur broke during procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036323 |
| MDR Report Key | 3840172 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-05-05 |
| Date Added to Maude | 2014-06-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUR |
| Generic Name | BUR |
| Product Code | HTT |
| Date Received | 2014-05-23 |
| Model Number | OVAL BUR |
| Catalog Number | 277-10-62 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | KALAMAZOO 49001 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-23 |