MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for HENRY SCHEIN 2020126 manufactured by Shenzhen Superline Technology Co., Ltd.
[102313135]
During a root canal procedure, a (b)(6) year old male patient had the hedstrom file break in the canal. The dentist had to extract the tooth in order to remove the broken file and the file was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2018-00004 |
| MDR Report Key | 7335896 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-14 |
| Date Facility Aware | 2018-02-16 |
| Report Date | 2018-03-13 |
| Date Reported to FDA | 2018-03-13 |
| Date Reported to Mfgr | 2018-03-13 |
| Date Added to Maude | 2018-03-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HENRY SCHEIN |
| Generic Name | HEDSTROM FILES |
| Product Code | EKW |
| Date Received | 2018-03-13 |
| Catalog Number | 2020126 |
| Lot Number | 17110103 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD |
| Manufacturer Address | CENTURY HOLIDAY PLAZA 9030 SHENNAN AVENUE NANSHAN, SHENZHEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-13 |