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.
[102302242]
During a root canal procedure, a (b)(6) year old female patient had the hedstrom file break in the canal. The patient was referred to see a specialist the next day to have the file removed. It is unknown if the broken file was able to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2018-00005 |
| MDR Report Key | 7336005 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-16 |
| 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 | 3 |
| 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 |