MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST PHOENIX; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

Catalog Number 884310

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

0 of 1 device has been returned for evaluation.Evaluation results will be submitted as they become available.

Event Description

This report summarizes 1 malfunction events.This report summarizes 1 malfunction event where a midwest phoenix handpiece overheated.The patient had a minor burn, no intervention was required.

• Brand Name: MIDWEST PHOENIX
• Type of Device: HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 10767386
• MDR Text Key: 215341207
• Report Number: 9614977-2020-00048
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 884310
• Type of Device Usage: N
• Patient Sequence Number: 1