MAUDE Adverse Event Report: PRO-MED INSTRUMENTS DORO TRANSLUCENT HEADREST SYSTEM; DORO HEAD CLAMPS

Model Number 3034 00CE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Anesthesiologist reported that the head appeared to have slipped in the doro skull pins.The neck was unstable at this point, but once stabilized the head was repositioned and secured; the skin behind the left ear was approximated with skin staples and bacitracin ointment.

• Brand Name: DORO TRANSLUCENT HEADREST SYSTEM
• Type of Device: DORO HEAD CLAMPS
• Manufacturer (Section D): PRO-MED INSTRUMENTS; botzinger strabe 38; 7911 ; freiburg im breisgau ; GM
• MDR Report Key: 6522172
• MDR Text Key: 73866344
• Report Number: MW5069343
• Device Sequence Number: 1
• Product Code: HBL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3034 00CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR