MAYFIELD 3-POINT HEAD REST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-07 for MAYFIELD 3-POINT HEAD REST * manufactured by Ohio Medical Instrument Co..

Event Text Entries

[68148] Headrest placed by neurosurgeon. While turning pt to prone position on the or table, 3-point headrest became dislodged causing a 6" left lateral scalp laceration. Pt turned back to supine position on stretcher. Laceration repaired by neurosurgeon. Surgery then proceeded as scheduled.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 114830
• MDR Report Key: 114830
• Date Received: 1997-08-07
• Date of Report: 1997-02-25
• Date of Event: 1997-02-13
• Date Facility Aware: 1997-02-13
• Report Date: 1997-02-25
• Date Reported to Mfgr: 1997-02-25
• Date Added to Maude: 1997-08-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAYFIELD 3-POINT HEAD REST
• Generic Name: NEUROSURGICAL HEAD CLAMP
• Product Code: HBM
• Date Received: 1997-08-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 112715
• Manufacturer: OHIO MEDICAL INSTRUMENT CO.
• Manufacturer Address: 3924 VIRGINIA AVE. CINCINNATI OH 45227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-08-07