MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PRO 1:5 CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875105

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Therefore, because medical intervention was required, this event is reportable per 21 cfr part 803.Hp didn't get hot during testing.Visible black mark on outside of cap.Cap sticking inwards position coming intact with rotor.Black grime built up on outside of cap.Replaced cap and turbine.Replaced water hoses and water valve.

Event Description

It was reported that a midwest e pro handpiece overheated and burned a patient.The doctor administered antibiotics to treat the burn.

• Brand Name: MIDWEST E PRO 1:5 CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12723616
• MDR Text Key: 279285909
• Report Number: 9614977-2021-00052
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/29/2021

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: 875105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention