MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-03 for HU-FRIEDY PCPMDBIU manufactured by Hu-friedy Mfg Co.,llc.
| Report Number | 1416605-2016-00001 |
| MDR Report Key | 5406601 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-03 |
| Date Mfgr Received | 2016-01-18 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2016-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer G1 | HU-FRIEDY MFG CO.,LLC |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY |
| Generic Name | DENTAL PROBE |
| Product Code | EIX |
| Date Received | 2016-02-03 |
| Returned To Mfg | 2016-01-18 |
| Model Number | PCPMDBIU |
| Catalog Number | PCPMDBIU |
| Lot Number | 0114 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG CO.,LLC |
| Manufacturer Address | 3232 N ROCKWELL ST CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |