MAUDE Adverse Event Report: INTEGRA INTEGRA ; MAYFIELD HEAD HOLDER

Model Number A-1059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/02/2017

Event Type  Injury  

Event Description

Patient's head slipped from a 3 point traction of mayfield and suffered a head laceration which required staples.

• Brand Name: INTEGRA
• Type of Device: MAYFIELD HEAD HOLDER
• Manufacturer (Section D): INTEGRA; plainsboro NJ 08536
• MDR Report Key: 6311713
• MDR Text Key: 66928217
• Report Number: MW5067752
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2017

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: A-1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2017
• 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 Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 73