MAUDE Adverse Event Report: W&H IMPEX INC WS-75 CONTRA ANGLE 20:1; DRILLING UNIT ACCESSORIES

Catalog Number 30065000

Device Problems Overheating of Device (1437); Defective Device (2588)

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

Event Type  Injury  

Event Description

Customer reported that when they pressed down on the foot pedal of the drill unit, they received a (thermometer) temperature gauge that the unit is overheating.The hand piece is also getting hot and would stop spinning.The error occurred during a procedure and they were unable to complete it.

• Brand Name: WS-75 CONTRA ANGLE 20:1
• Type of Device: DRILLING UNIT ACCESSORIES
• Manufacturer (Section D): W&H IMPEX INC; 6490 hawthorne drive; windsor, ontario N8T1J 9; CA N8T1J9
• MDR Report Key: 8203359
• MDR Text Key: 131700159
• Report Number: 0001038806-2018-01058
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30065000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2018
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention