MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for WEINGART PLIERS 866-2013 manufactured by Hu-friedy Mfg. Co. Llc.
[145608540]
Based on the lot number of the device, this device was produced prior to the udi deadline for class 1 devices, therefore udi is not present. The device is not implanted, therefore implant/explant dates are not applicable. Reprocessor does not apply. No known concomitant medical products and therapy dates.
Patient Sequence No: 1, Text Type: N, H10
[145608541]
On (b)(6) 2019 during a routine activation appointment while crimping the stops on a maxillary 19x25tma archwire the beak of an ormco weinghart plier broke, intra-orally. This resulted in a slip and fracture of the mesial incisal corner of the patients # 21 as well as a small laceration of the attached gingival apical to the #21 and a small cut in the maxillary lip near the vermillion border.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00010 |
| MDR Report Key | 8625869 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-20 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| 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 | 0 |
| Brand Name | WEINGART PLIERS |
| Generic Name | PLIER, ORTHODONTIC |
| Product Code | JEX |
| Date Received | 2019-05-20 |
| Model Number | 866-2013 |
| Catalog Number | 866-2013 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-20 |