MAUDE Adverse Event Report: HEAD DENTAL CORPORATION HENRY SCHEIN CONTRA ANGLE; HANDPIECE

Model Number CONTRA ANGLE 20,000 RPM

Device Problems Device Difficult to Maintain (3134); Device Handling Problem (3265)

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

Event Date 03/01/2022

Event Type  Injury  

Event Description

As the doctor was polishing the patient's finished filling, the small dome shaped washer on the end of the contra angle came loose and fell into the patient's mouth.Dr.Was unable to grab the piece with suction and it was quickly swallowed by the patient, not inhaled.The patient was taken to the emergency room and given a chest x-ray within the hour that the piece was swallowed.The x-ray revealed that the piece was not inhaled into the lungs but was swallowed into the digestive tract.A follow up x-ray was done some days later according to dr.The doctor has informed that the patient has not had any health complications arise since the event and believes at this time the patient is in good health.

• Brand Name: HENRY SCHEIN CONTRA ANGLE
• Type of Device: HANDPIECE
• Manufacturer (Section D): HEAD DENTAL CORPORATION; 17972 sky park circle,; suite j; irvine CA 92614
• MDR Report Key: 14028527
• MDR Text Key: 289687643
• Report Number: 3007007357-2022-00003
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

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: CONTRA ANGLE 20,000 RPM
• Device Catalogue Number: 100-5848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Distributor Facility Aware Date: 03/08/2022
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female