MAUDE Adverse Event Report: HU-FREIDY MFG CO., LLC EVEREDGE 2.0 SCALER; SCALER, PERIODONTIC

Model Number EVEREDGE 2.0

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2018

Event Type  malfunction  

Event Description

Pt was being treated when the toe of an instrument broke and became logged in the mesial of tooth #2.

• Brand Name: EVEREDGE 2.0 SCALER
• Type of Device: SCALER, PERIODONTIC
• Manufacturer (Section D): HU-FREIDY MFG CO., LLC; chicago IL 60618
• MDR Report Key: 7889430
• MDR Text Key: 120893987
• Report Number: MW5079893
• Device Sequence Number: 1
• Product Code: EMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVEREDGE 2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR