MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-08-13 for 866-2013 manufactured by Hu-friedy Mfg. Co. Llc.
| Report Number | 1416605-2019-00016 |
| MDR Report Key | 8889206 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-08-13 |
| Date of Report | 2019-08-12 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-07-16 |
| Date Added to Maude | 2019-08-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. STEPHANIE WASIELEWSKI |
| 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 |
| Generic Name | PLIER, ORTHODONTIC |
| Product Code | JEX |
| Date Received | 2019-08-13 |
| Returned To Mfg | 2019-07-25 |
| Model Number | 866-2013 |
| Catalog Number | 866-2013 |
| Lot Number | C18 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2019-08-13 |