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

Model Number	QS1010C
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	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blisters occur during the manufacturing process when air bubble are introduced into the liquid neoprene during the dipping process of the conformals (non assembled cushion).There are several factors in play during this process which may lead to blisters, however the most common root cause to these blisters is typically human factor during the dipping process.Visual inspection of the conformals occurs prior to assembly, however blisters may not always be apparent to the inspector.Following assembly, the cushions are over-inflated and held overnight in order to simulated the pressure a cushion is under with a user on it.Blister will typically rupture during this over-inflation testing.Cushions which fail the over-inflation testing and did not retain their over inflation, are further inspected for failure mode prior to rejection.Cushions which pass the over-inflation test have a final visual inspection performed prior to packaging.On the date of manufacture, 12-22-2025 1460 total cushions were inspected with 20 cushions rejected for blisters.For a 1.4% defect rate.In comparison, the blister defect rate for the calendar 2025 year is 3.5% defect rate with 7980 blisters out of 229912 cushions inspected.Production records were reviewed and there are no indications of any unusual events or other root causes for the blister failure.
Event or Problem Description
End user received a new roho cushion through their dealer, national seating and mobility.On first day of use, the cushion did not hold air.The user sat on the improperly inflated cushion all day and developed a stage 1 pressure sore, causing him to be restricted to bed rest and miss work.The cushion was replaced and the suspect cushion was returned to roho, inc.For inspection.Upon inspection, a manufacturing defect was identified which led to the leaking cushion.The defect observed is classified as a blister.A blister is an air pocket which forms during the neoprene forming process.Blisters are typically found duirng the inspection process through visual inspections and/or the overinflation test.Over inflation testing is designed to simulate the pressure of a person sitting on their cushion, which will typically cause blisters to rupture and leak.

• 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: 24400017
• Report Number: 3008630266-2026-00003
• Device Sequence Number: 18198729
• Product Code: KIC
• UDI-Device Identifier: 00613732054304
• UDI-Public: (01)00613732054304
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: QS1010C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG