MAUDE Adverse Event Report: DENTALEZ, INC., STARDENTAL DIVISION HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Handpiece malfunctioned releasing a burst of air and a section of the handpiece separated into the pt's mouth, pt did not swallow.

• Brand Name: HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTALEZ, INC., STARDENTAL DIVISION; 1816 colonial village ln; lancaster PA 17601
• MDR Report Key: 14111338
• MDR Text Key: 289348614
• Report Number: MW5108971
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male