MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for INTRA-ORAL BLADE 54003132 manufactured by Stryker.
[87041096]
It was reported that the intra-oral blade tip broke off while operating on the patient. No harm was done to the patient as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072218 |
| MDR Report Key | 6879285 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-14 |
| Date Added to Maude | 2017-09-20 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTRA-ORAL BLADE |
| Generic Name | INTRA-ORAL BLADE |
| Product Code | DZH |
| Date Received | 2017-09-19 |
| Catalog Number | 54003132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-19 |