MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-26 for AESCULAP MD955-63.5 * manufactured by Aesculap Sternal Oscillating Blade.
[22122711]
The blade broke off of the oscillating sternal saw immediately prior to use on patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1650201 |
| MDR Report Key | 1650201 |
| Date Received | 2010-03-26 |
| Date of Report | 2010-03-26 |
| Date of Event | 2010-03-23 |
| Report Date | 2010-03-26 |
| Date Reported to FDA | 2010-03-26 |
| Date Added to Maude | 2010-04-05 |
| 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 | BLADE, OSCILLATING, STERNAL SAW |
| Product Code | DWH |
| Date Received | 2010-03-26 |
| Model Number | MD955-63.5 |
| Catalog Number | * |
| Lot Number | 88178 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP STERNAL OSCILLATING BLADE |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-26 |