MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-14 for CORE INTRA-ORAL BLADE 5400-31-32 manufactured by Stryker.
[18110044]
Blade tip of stryker core intra-oral blade #5400-31-32 broke off during use. Both pieces removed from field. No apparent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1346534 |
| MDR Report Key | 1346534 |
| Date Received | 2009-03-14 |
| Date of Report | 2009-03-14 |
| Date of Event | 2009-02-10 |
| Report Date | 2009-03-14 |
| Date Reported to FDA | 2009-03-14 |
| Date Added to Maude | 2009-03-20 |
| 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 | CORE INTRA-ORAL BLADE |
| Generic Name | CORE INTRA-ORAL BLADE |
| Product Code | DZH |
| Date Received | 2009-03-14 |
| Returned To Mfg | 2009-02-26 |
| Model Number | NA |
| Catalog Number | 5400-31-32 |
| Lot Number | 31309010825501780*08255017 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-14 |