MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PAD SET WILSON FRAME TEMPUR PEDIC

Model Number	5319-37
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pad on the right side seems to have to much flexible give on the inside.When they lay the patient down on top of the frame the pad slides outwards causing the plastic frame beneath the pad to be exposed and cause pressure red marks on their patients.
Event or Problem Description
It was reported the pad on the right side seems to have to much flexible give on the inside.When they lay the patient down on top of the frame the pad slides outwards causing the plastic frame beneath the pad to be exposed and cause pressure red marks on their patients.
Additional Manufacturer Narrative
Pads were not returned, without return of the subject pads the cause could not be determined.

• Brand Name: PAD SET WILSON FRAME TEMPUR PEDIC
• Common Device Name: PAD
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 9799225
• Report Number: 2921578-2020-00012
• Device Sequence Number: 609813
• Product Code: JEA
• UDI-Device Identifier: 00842430102042
• UDI-Public: 00842430102042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5319-37
• Device Catalogue Number: 5319-37
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1