MAYFIELD HEADREST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-27 for MAYFIELD HEADREST * manufactured by Ohio Medical Inst..

Event Text Entries

[19698913] Pt placed in prone position with head in mayfield headrest with cranial spikes. After moving pt from surgical bed to post op bed, a 1 1/2" laceration above left ear was observed. Area prepped and closed with staples by physician.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013068
• MDR Report Key: 153466
• Date Received: 1998-02-27
• Date of Report: 1998-02-27
• Date of Event: 1998-02-26
• Date Added to Maude: 1998-03-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAYFIELD HEADREST
• Generic Name: HEAD POSITIONING DEVICE
• Product Code: HBM
• Date Received: 1998-02-27
• Returned To Mfg: 1998-02-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 149504
• Manufacturer: OHIO MEDICAL INST.
• Manufacturer Address: 4900 CHARLEMAR DR. CINCINNATI OH 45227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-02-27