MAUDE Adverse Event Report: W & H DENTALWERK BUERMOOS GMBH S-11 L G; SURGICAL HANDPIECE

Catalog Number 30057000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Full thickness (Third Degree) Burn (2696)

Event Date 10/15/2015

Event Type  Injury  

Event Description

During a normal root canal treatment the instrument got hot and the patient suffered a third degree burn on her lips.However, the injury will be presumably reversible and the patient do not require any surgical or medical intervention.

• Brand Name: S-11 L G
• Type of Device: SURGICAL HANDPIECE
• Manufacturer (Section D): W & H DENTALWERK BUERMOOS GMBH; buermoos 5111 ; AU 5111
• Manufacturer Contact: 53 ignaz-glaser-strasse; buermoos 5111 ; 3627462363
• MDR Report Key: 5198219
• MDR Text Key: 30338302
• Report Number: 9681479-2015-00004
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K080939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30057000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other