MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PILLOW, HEADREST, GT, 7 INCH; GENTLETOUCH

Model Number	1937
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Ulcer (2274); Blister (4537)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
We've been using the 1937 headrests for years now but lately we've been having a lot of issues with pressure ulcers on the face.
Event or Problem Description
Following a five hour prone spinal surgery, the patient had redness on forehead and chin.Subsequently blisters developed and leaked serosanguinous fluid.A wound consult was ordered, triple ointment was applied, and vaseline dressings were used.
Additional Manufacturer Narrative
Frequent monitoring and repositioning when required as described in the instructions may help to reduce the occurrence of such injuries.
Event or Problem Description
Following a five hour prone spinal surgery, the patient had redness on forehead and chin.Subsequently blisters developed and leaked serosanguinous fluid.A wound consult was ordered, triple ointment was applied, and vaseline dressings were used.

• Brand Name: PILLOW, HEADREST, GT, 7 INCH
• Common Device Name: GENTLETOUCH
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 12366583
• Report Number: 2921578-2021-00019
• Device Sequence Number: 11866827
• Product Code: CCX
• UDI-Device Identifier: 00842430101748
• UDI-Public: 00842430101748
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2022

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: 1937DZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/16/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/08/2021; 02/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Weight: 114 KG