MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. GENTLE TOUCH; HEADREST PILLOW

Model Number	1937
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had pressure sore to forehead after procedure.
Event or Problem Description
It was reported that the patient had pressure sore to forehead after procedure.Additional information was received; that during a posterior lumbar fusion procedure, injuries occurred when the patient's forehead was directly on the foam.Procedure was between 3.5 to 5 hours.Patient experienced redness, wound care was consulted upon discharge of patient.
Additional Manufacturer Narrative
The injuries occurred when the patient's forehead was directly on the foam.The user said that movement or readjustment of the patient position would be impossible during this type of case.There might be some momentary "peeking through" the face pillow to check for breathing tube placements but nothing major.User said that they noticed a change in the feel of foam.Rougher, changes in texture.However, no changes have been made in the manufacturing.Pma/510k: corrected information.
Event or Problem Description
It was reported that the patient had pressure sore to forehead after procedure.Additional information was received; that during a posterior lumbar fusion procedure, injuries occurred when the patient's forehead was directly on the foam.Procedure was between 3.5 to 5 hours.Patient experienced redness, wound care was consulted upon discharge of patient.
Additional Manufacturer Narrative
The injuries occurred when the patient's forehead was directly on the foam.The user said that movement or readjustment of the patient position would be impossible during this type of case.There might be some momentary "peeking through" the face pillow to check for breathing tube placements but nothing major.User said that they noticed a change in the feel of foam.Rougher, changes in texture.However, no changes have been made in the manufacturing.

• Brand Name: GENTLE TOUCH
• Common Device Name: HEADREST PILLOW
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8659687
• Report Number: 2921578-2019-00020
• Device Sequence Number: 2274735
• Product Code: CCX
• UDI-Device Identifier: 00842430101748
• UDI-Public: 00842430101748
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1937
• Device Catalogue Number: 1937
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 06/21/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/15/2019; 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other