MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E MICRO ELECTRIC MOTOR DETACHABLE HOSE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number 875050

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

In this event it was reported that a midwest e hose was crimped upon installation and caused the handpiece attachment to overheat and burn a patient's lip; no intervention was required.

Manufacturer Narrative

Since overheating of a handpiece could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability 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.

• Brand Name: MIDWEST E MICRO ELECTRIC MOTOR DETACHABLE HOSE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4669530
• MDR Text Key: 5732539
• Report Number: 1419322-2015-00023
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090937
• 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: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 875050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1