MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH S-12; SURGICAL HANDPIECE

Model Number SURGICAL HANDPIECE

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/15/2019

Event Type  Injury  

Event Description

During a dental surgica treatment the instrument got hot and it ended up in burning the patient's lip (2nd degree).The injury is reversible and the patient is under monitoring.After evaluation of the suspect device it came out that the adverse event occured due to wrong lubrication of the instrument.

• Brand Name: S-12
• Type of Device: SURGICAL HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: anja lindner ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 8517118
• MDR Text Key: 142037547
• Report Number: 9681479-2019-00002
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: J021300610001
• UDI-Public: +J021300610001
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K080939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SURGICAL HANDPIECE
• Device Catalogue Number: 30061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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): Hospitalization