MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PILLOW, GENTLETOUCH, 7 INCH RT; HEAD POSITIONER

Model Number	1937
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initially reported to manufacturer as dissatisfaction with the pillows.Further investigation revealed actual patient injuries.Unable to obtain details about the incidents.Treatment of injury unknown.Patient outcome unknown.Unknown which ett was used, why it did not fit through the ett slot, or where it was placed instead.Unknown if patient was positioned according to the instructions.
Event or Problem Description
The facility reported a deep tissue injury on the patient's chin.This is patient 3 of 3 reported by the same facility.This 7-inch pillow was described as higher and harder than the preferred pillow and it was reported that it had no space for the endotracheal tube and/or suction.The pillow was reportedly trimmed in some way in an attempt to reduce the pressure on the face.

• Brand Name: PILLOW, GENTLETOUCH, 7 INCH RT
• Common Device Name: HEAD POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11207641
• Report Number: 2921578-2021-00003
• Device Sequence Number: 4567798
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention