LEV 7887-050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-16 for LEV 7887-050 manufactured by Mizuho Orthopedic Systems, Inc..

MAUDE Entry Details

• Report Number: 2921578-2019-00031
• MDR Report Key: 8903051
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2019-08-16
• Date of Report: 2019-10-25
• Date of Event: 2019-07-29
• Date Mfgr Received: 2019-08-21
• Device Manufacturer Date: 2018-06-15
• Date Added to Maude: 2019-08-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ANNE LEBLANC
• Manufacturer Street: 30031 AHERN AVENUE
• Manufacturer City: UNION CITY CA 945871234
• Manufacturer Country: US
• Manufacturer Postal: 945871234
• Manufacturer Phone: 5104291500
• Manufacturer G1: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Manufacturer Street: 30031 AHERN AVENUE
• Manufacturer City: UNION CITY CA 945871234
• Manufacturer Country: US
• Manufacturer Postal Code: 945871234
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: 2921578-10/16/2019-001-R
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LEV
• Generic Name: HEAD POSITIONING UNIT
• Product Code: JEA
• Date Received: 2019-08-16
• Returned To Mfg: 2019-08-21
• Model Number: 7887-050
• Catalog Number: 7887-050
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Manufacturer Address: 30031 AHERN AVENUE UNION CITY CA 945871234 US 945871234

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-16