MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for HEIDBRINK ROOT TIP PICK EHB1 manufactured by Hu-friedy Mfg. Co. Llc.
[139671428]
Patient weight, ethnicity and race unknown. No relevant history. 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. User facility/importer does not apply.
Patient Sequence No: 1, Text Type: N, H10
[139671429]
The dentist was performing an extraction when tooth #13 luxated and a root tip fractured. The dentist tried to grasp the tip but about 4mm of the tip of the root pick broke off. An x-ray was performed in the office and no metallic materials were found in sinus or nasal cavities. Patient was referred to radiology at hospital for further imaging as well as a urinalysis was performed. The hospital reports stated all x-rays were clear of the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00006 |
| MDR Report Key | 8445945 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 1989-01-01 |
| Date Added to Maude | 2019-03-22 |
| 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 | HEIDBRINK ROOT TIP PICK |
| Generic Name | ELEVATOR, SURGICAL, DENTAL |
| Product Code | EMJ |
| Date Received | 2019-03-22 |
| Returned To Mfg | 2019-03-12 |
| Model Number | EHB1 |
| Catalog Number | EHB1 |
| Lot Number | 1989 |
| 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 | 2019-03-22 |