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

Model Number	QS89
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user called roho for a warranty replacement of her roho quad select qs89 cushion due to the cushion not holding air.The user stated she noticed the cushion was not holding air during a doctors appointment a couple of weeks prior to the call.She requested a replacement because she had pressure sore injuries.The user did not specify if the pressure sore was a result of the leaking cushion or if the doctor appointment was in relation to the pressure sores.At the time of this submission, roho has been unsuccessful with establishing contact with the user.Since the severity of the pressure sores and the relation of the pressure sores to the leaking cushion could not be established, roho is reporting this as a potential serious injury.There are no indications of any manufacturing issues when reviewing the dhr.This cushion leaked after approximately a year of usage.Each cushion is shipped with a patch/repair kit with instructions for users to patch their cushions if minor leaks occur.This user did not give any indication if she had attempted to repair the leak in her cushion prior to requesting a warranty replacement.Roho will continue to attempt to establish contact with the user and will update this report if any further relevant information is discovered.
Event or Problem Description
User called in with a complaint that his qs89c cushion is leaking.She has a pressure sore injury.

• 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 IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 23783324
• Report Number: 3008630266-2025-00009
• Device Sequence Number: 10144183
• Product Code: KIC
• UDI-Device Identifier: 00613732054120
• UDI-Public: (01)00613732054120
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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 Expiration Date: 07/25/2024
• Device Model Number: QS89
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Female