MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE

Model Number 6875

Device Problem Insufficient Information (3190)

Patient Problem Irritation (1941)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

The cause of the patient's vaginal redness and irritation is unknown.The treatment and outcome are unknown.It is unclear why the initial reporter described the illness or injury as disabling/permanent.It is unknown whether the illness or injury is related to the use of the operating table.

Event Description

It was reported the patient had complaints of vaginal redness and irritation post-surgery after being on the orthopedic table.

• Brand Name: HANA
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 8860364
• MDR Text Key: 153251515
• Report Number: 2921578-2019-00026
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other