MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-11 for HU-FRIEDY BRACKET REMOVER 678-220L manufactured by .
[16677659]
On (b)(6) 2012 the patient was having brackets removed, the plier being used broke and caused a horizontal fracture on tooth number 12. The tooth was temporary fixed and the patient was sent to the (b)(6) medical center of the university of (b)(6) where a root canal treatment was performed on tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2012-00002 |
| MDR Report Key | 2625834 |
| Report Source | 06 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-03-23 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2012-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA VRABIE |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY BRACKET REMOVER |
| Generic Name | 678-220L |
| Product Code | EJB |
| Date Received | 2012-06-11 |
| Model Number | 678-220L |
| Catalog Number | 678-220L |
| Lot Number | T5 |
| ID Number | NA |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-11 |