MAUDE Adverse Event Report: MIZUHO OSI PILLOW, GENTLETOUCH, 7 INCH RT; PATIENT POSITIONER/HEADREST

Model Number	1937
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Tissue Injury (4559)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced deep tissue injury on forehead using gentletouch pillow during 8+ hour procedure.
Additional Manufacturer Narrative
Based on the information obtained from the investigation, the patient was positioned prone on the pillow for more than 8 hours that led to the tissue injury.It is deemed as an user error as the instruction for use (ifu) include several warnings such as: 1.Frequently monitor the patient's neck, head, eyes, nose and mouth to ensure that a safe position is maintained, and the et tube has not been kinked or displaced.Failure to do so can lead to serious adverse consequences including blindness, failure to ventilate, or pressure injuries to the face.2.Some erythema may result from skin contact with the materials in this product or from compression during prolonged cases 3.Not for continuous use of more than 8 (eight) hours there are no reported or observed issues with the device.This case represents the elevated risk of pressure injuries due an imbalance between the weight of the patient and the recommended duration of procedure/device use.As mentioned above, the instructions for use (ifu) provides necessary warnings and also options for for users to be informed on selection of proper pre-operative and intra-operative procedures.Likewise, national pressure injury advisory panel guidelines point to similar preventive measures to be considered while positioning the patient in prone position and recognizing the risk factors.
Event or Problem Description
It was reported that the patient experienced deep tissue injury on forehead using gentletouch pillow during 8+ hour procedure.

• Brand Name: PILLOW, GENTLETOUCH, 7 INCH RT
• Common Device Name: PATIENT POSITIONER/HEADREST
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17344729
• Report Number: 2921578-2023-00011
• Device Sequence Number: 12498051
• Product Code: CCX
• UDI-Device Identifier: 00842430101748
• UDI-Public: 00842430101748
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown