MAUDE Adverse Event Report: ROHO, INC. ROHO QUADTRO SELECT HIGH PROFILE CUSHION; WHEELCHAIR CUSHION

Model Number	QS1111C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
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 single compartment, sensor ready, enhancer, quadtro select, contour select 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." the wound care facility report stated the user did not know how long she had been experiencing the pressure sore or how long their cushion had been improperly inflated.At the time of this report, the cushion from the complaint has not been received for inspection.User was provided with a replacement cushion under warranty.
Event or Problem Description
End user received treatment for a stage 3 pressure ulcer at the wound care clinic.Staff at the clinic determined the user needed a new roho cushion since the users current roho cushion was not holding air.The prescription for the replacement cushion was submitted to national seating and mobility on (b)(6) 2026, who then reported this to roho, inc.The user was unable to specify how long since her pressure ulcer had developed, once she discovered drainage she went to the would care clinic for treatment.

• 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 ; 6185412901
• MDR Report Key: 25323703
• Report Number: 3008630266-2026-00005
• Device Sequence Number: 13262590
• Product Code: KIC
• UDI-Device Identifier: 00613732054366
• UDI-Public: (01)00613732054366
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: QS1111C
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White