MAUDE Adverse Event Report: ROHO, Inc. ROHO Hybriid Select Cushion; Wheelchair Cushion

Model Number	HS1517C
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported to spinlife that she had been hospitalized due to a pressure injury on her left buttock.She was also in the hospital for 2 days receiving meds for the infection.The sore will not heal and she is still working with wound care to try to get it under control to some extent.The wound was initially observed on (b)(6) 2026 but not reported to roho, inc.Until 7/13/2026.User reported too spinlife her phhysical therapist had added air to her cushion but she did not know if it had been inflated properly.Spinlife has not provided end user information for additional follow up information.
Additional Manufacturer Narrative
Each roho dry floatation product in this manual is an adjustable, air-filled, cellular-design wheelchair support surface.There is no weight limit, yet the cushion must be properly sized to the individual.Each of the following products utilizes dry floatation technology and is intended to conform to an individual's seated shape to provide skin/ soft tissue protection, positioning, and an environment to facilitate wound healing.The ifu for roho hybrid select cushion states "skin/soft tissue breakdown can occur due to a number of factors, which vary by individual.Check skin frequently, at least once a day.Redness, bruising, or darker areas (when compared to normalskin) may indicate superficial or deep tissue injury and should be addressed.If there is any discoloration to skin/soft tissue, stop use immediately.If the discoloration does not disappear within 30 inutes after disuse, immediately consult a healthcare professional." the ifu cuhsion setup instructions also states "do not use a product that is underinflated or overinflated, because 1) the product benefits will be reduced or eliminated, resulting in an increased risk to skin and other soft tissue, and 2) the individual may become unstable and vulnerable to falling.Carefully follow the instructions for inflation, placement and hand check.If the product does not appear to be holding air, or if unable to inflate or deflate the product, see "troubleshooting".Immediately contact the equipment provider, distributor, or customer support if the problem persists.After setting up the cushion the first time, perform a hand check frequently, at least once a day.When the cushion is used by a different individual or in a different wheelchair, repeat cushion setup.Follow the hand check instructions in this manual." at the time of this report, the cushion from the complaint has not been received for inspection.

• Brand Name: ROHO Hybriid Select Cushion
• Common Device Name: Wheelchair Cushion
• Manufacturer (Section D): ROHO, Inc.; 1501 s. 74th st.; belleville IL 62223
• Manufacturer (Section G): ROHO, Inc.; 1501 south 74th st.; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; +1(618)541-2901
• MDR Report Key: 50262989
• Report Number: 3008630266-2026-00007
• Device Sequence Number: 10020908
• Product Code: KIC
• UDI-Device Identifier: 00613732109134
• UDI-Public: (01)00613732109134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: HS1517C
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 150 LB