MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

There have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.

Event Description

In this event, a doctor reported that a midwest e plus 1:5 attachment overheated and burned a patient.The doctor administered magic mouthwash (contains benadryl, lidocaine and maalox) to treat the burn.The doctor followed-up with the patient three days later and the patient was "fine.".

• Brand Name: MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6590457
• MDR Text Key: 75969145
• Report Number: 1419322-2017-00105
• 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
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 875205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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