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

Model Number	QS1011C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End user has acquired legal counsel.The cushion has not been returned to roho for inspection per request of the end users legal counsel.The cushion is being held by the distributor.
Event or Problem Description
Distributor (b)(4) delivered a roho cushion qs1011c on june 15,2025.After delivery, the end user noticed the cushion was flat by the end of the day.A technician from the distributor inspected the cushion and determined the isoflo valve was leaking.A new cushion was issued under warranty.After the initial warranty claim was received, the end user contacted the distributor in order to report that a pre-existing pressure sore injury had reopened due to the cushion going flat.The end user claimed the pressure sore is now a stage 10 wound.

• Brand Name: ROHO® QUADTRO SELECT® HIGH PROFILE¿ CUSHION
• Common Device Name: CUSHION, WHEELCHAIR
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th st; belleville IL 62223
• Manufacturer (Section G): ROHO, INC,; 1501 s. 74th st.; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6182776518
• MDR Report Key: 22819785
• Report Number: 3008630266-2025-00005
• Device Sequence Number: 5738917
• Product Code: KIC
• UDI-Device Identifier: 00613732054328
• UDI-Public: (01)00613732054328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: QS1011C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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: 30 YR
• Patient Sex: Unknown