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

Model Number 3034 00CE (PART NO)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 04/19/2016

Event Type  Injury  

Event Description

During case, dr noted pt has slid down the bed while in skull clamp.When drapes were removed noted 3 cm deep laceration at pt.Pin sites.Pt's feet were off of the bed.

• Brand Name: DORO TRANSLUCENT HEADREST SYSTEM
• Type of Device: DORO HEAD CLAMPS
• Manufacturer (Section D): PRO-MED ; botzinger strsse 38; freiburg im breisgau 7911 ; GM 7911
• MDR Report Key: 6533486
• MDR Text Key: 74197322
• Report Number: MW5069449
• 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 (PART NO)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2017
• 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: 78 YR