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

Model Number	QS67C
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Interview with the users mother occurred on (b)(6) 2026.During the interview she identified that this is the third cushion she has had a leak in the same quadrant.She was directed to consult with the seating specialist who prescribed the cushion to determine if the cushion is properly sized.Patch repair kits are provided with each cushion and are also available upon request through customer service.The instructions provided in the ifu state "inflate the cushion.Inspect the quick disconnect (sensor ready cushion), the inflation valve(s), and hose(s) for damage.Confirm that the inflation valve(s) are completely closed.Look for holes in the cushion.If very small holes or no holes are visible, follow the instructions in the repair kit provided with the product." she stated she was unable to locate the leak in order to try and patch the cushion.Her son did require medical treatment from his doctor for the pressure injury which then required 3 days of bed rest and missing school for healing.Currently the wound is under control.
Event or Problem Description
User's mother called to request a warranty replacement of her sons qs67 cushion due to a leak in the right back quadrant.The cushion had gone flat in that quadrant several times in the previous several days and now her son has developed a pressure sore.

• 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: 24011232
• Report Number: 3008630266-2026-00001
• Device Sequence Number: 9250653
• Product Code: KIC
• UDI-Device Identifier: 00613732054007
• UDI-Public: (01)00613732054007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: QS67C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/08/2026
• 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: 10 YR
• Patient Sex: Male