• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

A-DEC, INC. ADEC ELECTRIC MOTOR UNIT, OPERATIVE DENTAL Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADEC ELECTRIC MOTOR
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
A-DEC, INC.
MDR Report Key11260132
MDR Text Key229884064
Report NumberMW5099102
Device Sequence Number1
Product Code EIA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF 54.0478.00
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/29/2021 Patient Sequence Number: 1
-
-