MAUDE Adverse Event Report: ADS OR AJAX DENTAL/GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD AJ16 DENTAL OPERATORY UNIT; UNIT, OPERATIVE DENTAL

Model Number AJ16

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2023

Event Type  Injury  

Event Description

I sat in an (b)(6) with model number aj16 and noticed that the chair was slowing sinking in its place.After a brief moment sitting in it, the chair suddenly collapsed, dropped to the floor, and i was flung off the dental chair.I started noticing hydraulic fluid all over the floor.I mentioned this to other colleagues in the industry and they said that they have experienced similar issues.This chair should not be allowed to be sold to dentists and a proper recall of all their products should be conducted.

• Brand Name: AJ16 DENTAL OPERATORY UNIT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): ADS OR AJAX DENTAL/GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD
• MDR Report Key: 18365276
• MDR Text Key: 331103021
• Report Number: MW5149397
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AJ16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian