MAUDE Adverse Event Report: A-DEC, INC. A-DEC EA-53 ELECTRIC HANDPIECE MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Model Number EA-53

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Water leaking out of the bottom of the handpiece motor.Fda safety report id# (b)(4).

• Brand Name: A-DEC EA-53 ELECTRIC HANDPIECE MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): A-DEC, INC.
• MDR Report Key: 11921768
• MDR Text Key: 254098656
• Report Number: MW5101651
• Device Sequence Number: 1
• Product Code: EBW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EA-53
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1