MAUDE Adverse Event Report: A-DEC, INC. ADEC ELECTRIC MOTOR; UNIT, OPERATIVE DENTAL

Catalog Number REF 54.0478.00

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  Injury  

Event Description

Can no longer twist the electric handpiece motor on the tubing.Fda safety report id # (b)(4).

• Brand Name: ADEC ELECTRIC MOTOR
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): A-DEC, INC.
• MDR Report Key: 11260132
• MDR Text Key: 229884064
• Report Number: MW5099102
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/27/2021

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: No Information
• Device Catalogue Number: REF 54.0478.00
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention