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

• Device Model Number: 430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/26/2019 Patient Sequence Number: 1