MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS PLUS; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 792400

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a midwest stylus plus handpiece overheated during use and burned a patient's cheek.The doctor prescribed medication to help the wound heal.

Manufacturer Narrative

Hp arrived with button stuck down on cap and mark in middle of button.Dent in cap causing button to stick.The cartridge and cap both had signs of excessive use/abuse without proper maintenance.

• Brand Name: MIDWEST STYLUS PLUS
• Type of Device: HANDPIECE, AIR-POWERED, 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: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 13418123
• MDR Text Key: 284863149
• Report Number: 9614977-2022-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 792400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention