MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH DU 900; DENTAL DRILL UNIT

Catalog Number 00993203

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

After analysing the product, there was no problem found.The analysis showed it was normal wear and tear.

Event Description

It was reported that an error occured during the procedure with the drill.Another tool could not be used and the patient that to come back to complete the procedure.

• Brand Name: DU 900
• Type of Device: DENTAL DRILL UNIT
• 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: 7845114
• MDR Text Key: 119151414
• Report Number: 9681479-2018-00005
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00993203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention