MAUDE Adverse Event Report: HENRY SCHEIN / DENTAL EZ, INC. STARDENTAL DIV SW 430; HANDPIECE, AIR - POWERED, DENTAL

Model Number 430

Device Problem Material Separation (1562)

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

Event Date 08/15/2019

Event Type  Injury  

Event Description

Pt was having dental procedure when hand piece came apart in their mouth.Fda safety report id# (b)(4).

• Brand Name: SW 430
• Type of Device: HANDPIECE, AIR - POWERED, DENTAL
• Manufacturer (Section D): HENRY SCHEIN / DENTAL EZ, INC. STARDENTAL DIV; melville NY 11747
• MDR Report Key: 8935382
• MDR Text Key: 155780242
• Report Number: MW5089327
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR