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

Model Number S-12

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The handpiece was analysed in w&h service station.There were no damages identified.It functions accordingly during the test procedure.

Event Description

The end-user stated that the tip of the handpiece s-12 got hot and burned the patient.Also the assistant got burn marks after touching the handpiece.

• 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 duerager ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 8295675
• MDR Text Key: 134705171
• Report Number: 9681479-2019-00001
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: S-12
• Device Catalogue Number: 30061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1