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

Model Number	QS1010
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The users spouse, who is his caregiver, is a nurse who discovered a pressure sore had developed while she was away at work.She found the right rear quadrant of her husbands cushion had gone flat and would no longer hold air.She treated her husbands sore and put him onto bed rest for the wound to heal.The cushion was replaced under warranty.Upon receipt of the new cushion, the suspect cushion was returned to roho for inspection.Roho inspected this cushion 4/29/2026 and discovered a hole was found on one of the cells.The cushion was dissected and the cell with the hole was found to have a crease.A crease indicates that a fold formed in the neoprene which created a weak spot for a hole to form in the neoprene.
Event or Problem Description
User's caregiver called that her husbands roho quad secect cushion had stopped holding air in the right rear quadrant.During the time the caregiver was away from the house for work, her husband developed a pressure sore from sitting on the flat quadrant.

• 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 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 25191060
• Report Number: 3008630266-2026-00004
• Device Sequence Number: 13368878
• Product Code: KIC
• UDI-Device Identifier: 00613732054304
• UDI-Public: (01)00613732054304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: QS1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male