MAUDE Adverse Event Report: DENTAL OPERATING CHAIR; UNIT, OPERATIVE DENTAL

Device Problems Break (1069); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Contamination /Decontamination Problem (2895)

Patient Problems Unspecified Infection (1930); Pain (1994); Skin Tears (2516); Swelling/ Edema (4577)

Event Date 05/14/2021

Event Type  Injury  

Event Description

After multiple visits to dr.(b)(6), many issues have occurred.Within the dental office, a dog walk around coming into contact to all surfaces including operating seat and dental equipment.The doctor will interact and pet the dog with gloves on and proceed to putting his unwashed gloved hands to my mouth.Additionally, while in the waiting room, it was seen that mice were running across the heating battery.When i mentioned this to the dentist, he laughed and replied that it is fine.When seated on the operating chair, which is broken, a cockroach was crawling on it.During dental procedures, the dentist uses expired and/or defective cement compound matter for crown application.The cement flakes off after the first brushing.The loss of cement leaves behind large gaps between the crown and the tooth inside in which food and liquids that get stuck in there.Also, the tooth that needs the crown is not cleaned and the cavity is left and covered by the crown.During the procedure, the dentist carelessly cuts the nerves of the gum, resulting in a lot of pain.After using his dirty hands, this results in severe pain and infection of the swollen gum and untreated tooth.The gums still remains swollen and painful.Fda safety report id # (b)(4).

• Brand Name: DENTAL OPERATING CHAIR
• Type of Device: UNIT, OPERATIVE DENTAL
• MDR Report Key: 11976205
• MDR Text Key: 255957342
• Report Number: MW5101816
• Device Sequence Number: 2
• Product Code: EIA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 77