MAUDE Adverse Event Report: HALL; HALL DENTAL DRILL

Model Number SURGAIRTOME TWO

Device Problem Naturally Worn (2988)

Patient Problem Burn(s) (1757)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

During dental; extraction procedure hall drill became overheated and irritated lateral portion of tongue requiring sutures tc keep tissue intact.

• Brand Name: HALL
• Type of Device: HALL DENTAL DRILL
• MDR Report Key: 15713799
• MDR Text Key: 302941840
• Report Number: 15713799
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURGAIRTOME TWO
• Device Lot Number: 5058-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Distributor Facility Aware Date: 10/28/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White