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

Model Number	QS1010C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported his quad select cushion was leaking in one fo the front quadrants of the cushion.The cushion was still under warranty and a replacement cushion was sent to the user.The user was requested to return the cushion with the complaint for evaluation by roho.At the time of this report the cushion has not been returned to roho.
Event or Problem Description
User called in with a complaint that his qs1010c cushion is leaking.He has developed a pressure sore from sitting on a flat cushion.

• Brand Name: ROHO QUADTRO SELECT HIGH PROFILE CUSHION
• Common Device Name: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th street; 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: 23550220
• Report Number: 3008630266-2025-00007
• Device Sequence Number: 18571665
• Product Code: KIC
• UDI-Device Identifier: 00613732054304
• UDI-Public: (01)00613732054304
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/13/2025

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: QS1010C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male