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

Model Number	QS88C
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cushion was not returned to roho, inc.From the distributor.An evaluation could not be performed.The user manual includes a warning to discontinue use of a defective product that reads as follows: "check skin frequently, at least once a day.Redness, bruising, or darker areas (when compared to normal skin) may indicate superficial or deep tissue injury and should be addressed.If there is any discoloration to skin/soft tissue, stop use immediately.If the discoloration does not disappear within 30 minutes after disuse, immediately consult a healthcare professional.- check inflation frequently, at least once a day.- do not use a product that is underinflated or overinflated, because 1) the product benefits will be reduced or eliminated, resulting in an increased risk to skin and other soft tissue." during interview with the user, he stated he was in the habit of performing the hand check as described in the user manual.The replacement cushion he received was functioning properly.Even though the cushion was not returned for evaluation, the most likely root cause is due to the nature of the neoprene cushion wearing through use and developing leaks.This is a know failure mode but has been determined to have a greater benefit to use than the risk of leaks presents.Patch kits along with instructions are provided to the users with the cushions in order to repair small leaks as they occur.
Event or Problem Description
The user reported to his dealer his roho quad select cushion had developed a leak and was not holding air.The client stated he had developed a pressure injury due to the leaking cushion.

• Brand Name: ROHO® QUADTRO SELECT® HIG 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 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 21922537
• Report Number: 3008630266-2025-00002
• Device Sequence Number: 15711205
• Product Code: IMP
• UDI-Device Identifier: 00613732054106
• UDI-Public: (01)00613732054106
• 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: 505
• Remedial Action: Replace
• Type of Report: Initial

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: QS88C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: White