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

Model Number 0.553.1390

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/25/2019

Event Type  Injury  

Event Description

The mfrs advise against reprocessing for the current detachable couplers within our unit.However the fda and the cdc state, "if an item can be detached from the dental unit, it should be reprocessed.Matters on this issue are being discussed until transition to couplers that can be reprocessed.(b)(6).

• Brand Name: MULTIFLEX COUPLING
• Type of Device: HANDPIECE, AIR POWERED, DENTAL
• Manufacturer (Section D): KAVO DENTAL / KAVO DO BRASIL IND. COM. LTDA.
• MDR Report Key: 8692805
• MDR Text Key: 147944380
• Report Number: MW5087303
• 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: Dental Assistant
• Type of Report: Initial
• Report Date: 03/26/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0.553.1390
• Device Catalogue Number: Midwest
• Device Lot Number: 1059491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention