MAUDE Adverse Event Report: ROHO, INC., ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION; CUSHION, FLOTATION

Model Number	1R1111
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation of both the original complaint cushion and the replacement cushion were unable to identify any manufacturing defects with the cushions.Interviews with the user identified usage error as the most likely root cause.The user identified he frequently leans to one side in his chair.By using a single chamber air cushion, leaning to one side causes the air to displace, allowing the user to bottom out on the leaning side.Since the user was identified to be using the wrong type of cushion, he was recommended to return to his clinician for re-evaluation of the type of cushion he should be using.
Event or Problem Description
User has reported his cushion leaks within about 30 minutes of inflation, causing him to bottom our in his wheelchair.

• Brand Name: ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION
• Common Device Name: CUSHION, FLOTATION
• Manufacturer (Section D): ROHO, INC.,; 1501 s. 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 23096048
• Report Number: 3008630266-2025-00006
• Device Sequence Number: 8766242
• Product Code: KIC
• UDI-Device Identifier: 00613732037291
• UDI-Public: (01)00613732037291
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: Lay User/Patient
• Device Model Number: 1R1111
• Device Catalogue Number: 1R1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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