MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for HANDPIECE manufactured by Henry Schein.
[142924336]
Dr was suing dental hand piece when the bur came out of the hand piece and pt swallowed it. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086065 |
| MDR Report Key | 8541122 |
| Date Received | 2019-04-22 |
| Date Added to Maude | 2019-04-23 |
| 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 | HANDPIECE |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2019-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HENRY SCHEIN |
| Manufacturer Address | MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |