MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for HU-FRIEDY 100 manufactured by Hu-friedy Mfg. Co. Llc.
[63085993]
Patient was having scaling done when the tip of the scaler broke and the patient is believed to have swallowed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066817 |
| MDR Report Key | 6193178 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-17 |
| Date Added to Maude | 2016-12-21 |
| 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 | HU-FRIEDY |
| Generic Name | ULTRA SONIC SCALER |
| Product Code | EMN |
| Date Received | 2016-12-19 |
| Model Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO. LLC |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-19 |