MAUDE Adverse Event Report: ROHO, Inc. ROHO Quadtro Select High Profile Cushion; Wheelchair Cushion

Model Number	QS910C
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported that their end user reported that she had fallen out of her chair and broke a hip.The user asserted that her roho cushion had gone flat, causing her to lose her balance and fall from the chair.The user had reported difficulty with keeping the cushion inflated requiring daily inflation.
Event or Problem Description
Distributor reported that their end user reported that she had fallen out of her chair and broke a hip.The user asserted that her roho cushion had gone flat, causing her to lose her balance and fall from the chair.The user had reported difficulty with keeping the cushion inflated requiring daily inflation.
Additional Manufacturer Narrative
The end user was interviewed on 8/26/2026.During the interview, the user stated that she had experienced difficulty with her cushion, needing to add air to it daily.The fall occurred when she was reaching for something, and lost her balance falling from her chair.She noted that at the time of her fall, her prosthetic leg had also folded under the chair, which possibly contributed to the fall.The ifu for roho hybrid select cushion states "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 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." a replacement cushion was provided under warranty and the suspect cushion was requested for return inspection.The distributor took the suspect cushion after delivering the replacement cushion to the end user.At the time of this report, the cushion from the complaint has not been received for inspection.
Additional Manufacturer Narrative
The end user was interviewed on 8/26/2026.During the interview, the user stated that she had experienced difficulty with her cushion, needing to add air to it daily.The fall occurred when she was reaching for something, and lost her balance falling from her chair.She noted that at the time of her fall, her prosthetic leg had also folded under the chair, which possibly contributed to the fall.The ifu for roho hybrid select cushion states "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 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." a replacement cushion was provided under warranty and the suspect cushion was requested for return inspection.The distributor took the suspect cushion after delivering the replacement cushion to the end user.At the time of this report, the cushion from the complaint has not been received for inspection.Update 9/25/2026: the suspect cushion was received and inspected by roho inc.On 9/18/2026.The cushion was inspected and no signs of defects were observed.Over-inflation testing was performed on the cushion and the cushion maintained the over-inflation status after 24 hour hold time.The outcome of the inspection was no problem found.

• Brand Name: ROHO Quadtro Select High Profile 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: 50498119
• Report Number: 3008630266-2026-00008
• Device Sequence Number: 21194940
• Product Code: KIC
• UDI-Device Identifier: 00613732054229
• UDI-Public: (01)00613732054229
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: QS910C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 150 LB