MAUDE Adverse Event Report: MIZUHO OSI PILLOW, GENTLETOUCH, 7 INCH RT; PATIENT POSITIONING ACCESSORY

Model Number	1937
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Blister (4537)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gentletouch headrest pillow was not inflated enough and was used on the patient for surgical support despite the warnings mentioned in the instructions for use that say "do not use a pillow that has not fully expanded".Based on this information received from the investigation, the incident was deemed as a user error with failure to follow instructions.
Event or Problem Description
It was reported that a patient got injured due to the use of patient support pillow during the surgery.

• Brand Name: PILLOW, GENTLETOUCH, 7 INCH RT
• Common Device Name: PATIENT POSITIONING ACCESSORY
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16865778
• Report Number: 2921578-2023-00005
• Device Sequence Number: 5796598
• Product Code: CCX
• UDI-Device Identifier: 00842430101748
• UDI-Public: 00842430101748
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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
• Device Lot Number: APF220418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian