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

Model Number	QS1111MPC
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: ROHO Quadtro Select Mid 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: 50948620
• Report Number: 3008630266-2026-00009
• Device Sequence Number: 10348393
• Product Code: KIC
• UDI-Device Identifier: 00613732108342
• UDI-Public: (01)00613732108342
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: QS1111MPC
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• 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