MAUDE Adverse Event Report: KAVO DO BRASIL IND. COM. LTDA. MULTIFLEX LUX COUPLING MIDWEST; DENTAL COUPLER HANDPIECE, AIR POWERED

Lot Number 0.553.1390

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Dental coupling device ifus state that external chemical disinfection (wiping, not immersion) is all that is needed between patients.Per the dental evaluation and consultation service, fda and cdc guidance states that dental coupling devices should be sterilized between patients.

• Brand Name: MULTIFLEX LUX COUPLING MIDWEST
• Type of Device: DENTAL COUPLER HANDPIECE, AIR POWERED
• Manufacturer (Section D): KAVO DO BRASIL IND. COM. LTDA.
• MDR Report Key: 8459638
• MDR Text Key: 140440915
• Report Number: MW5085233
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0.553.1390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1