MAUDE Adverse Event Report: UNKNNOWN DENTAL DRILL; DRILL, DENTAL, INTRA ORAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 03/11/2019

Event Type  Injury  

Event Description

A big dog runs around the dental office and comes into contact with all the instruments and medicines.The dog touches everything with its paws and licks everything.The dog is all over the dentist, while the dentist picks up the dog.The dentist uses all of the equipment and medicine on patients including myself.This gave me a severe infection in my gums.This caused swelling in the gums.The dog was distracting the dentist and the dentist damaged my teeth using the instruments in hand.This affected the canal and wall of the tooth.As well as cut into my gums.The dog lives in the office.There is a big dog cage and food bowl in one of the offices in the dentistry.Dentist: (b)(6) d.M.D., m.S., (b)(6).

• Brand Name: DENTAL DRILL
• Type of Device: DRILL, DENTAL, INTRA ORAL
• Manufacturer (Section D): UNKNNOWN
• MDR Report Key: 8735817
• MDR Text Key: 149479585
• Report Number: MW5087639
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 77