MAUDE Adverse Event Report: ROHO, INC. ROHO LOW PROFILE SINGLE COMPARTMENT CUSHION; WHEELCHAIR CUSHION

Model Number	1R109LPC
Medical Device Problem Codes	Gas/Air Leak (2946); Material Integrity Problem (2978); Naturally Worn (2988)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User called to report he had just returned from vacation and his cushion developed a leak while on vacation.He has patched the cushion several times but was unable to get the patch to stop the leak.He stated that he has developed a pressure sore on his buttocks due to the deflated cushion.The cushion was returned to roho for evaluation on 11/6/2025.Evaluation of the cushion showed one of the patches was leaking air.The cell with the leaking patch was dissected and it was determined there was a tear under the patch which was likely too large for the patch to stop the leak.There was another patch on the same cell which also had a tear underneath it but this patch was properly sealed.The inside of the leaking cell showed signs of fatigue including a crease.A replacement cushion was provided to the user.
Additional Manufacturer Narrative
Inspection of the returned cushion identified the root cause to be usual wear and tear evidenced by the fatigued appearance of the inner surfaces including creases.The tears observed may have been a result of an original leak which was torn in the repair process.The cushion was still within the warranty period and replaced for the end user.The failure mode observed is a known failure mode.Patch/repair kits are provided with the cushions in order to allow the end users to repair minor leaks.Inspection identified the user in this case was aware of this since there were several patches applied to the cushion.The leak for this complaint became non-repairable once the neoprene tore and became too large to reasonably patch.

• Brand Name: ROHO LOW PROFILE SINGLE COMPARTMENT 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 street; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th street; belleville, IL 62223 ; 6185412901
• MDR Report Key: 23657766
• Report Number: 3008630266-2025-00008
• Device Sequence Number: 10027380
• Product Code: KIC
• UDI-Device Identifier: 00613732005535
• UDI-Public: (01)00613732005535
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/26/2025

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
• Device Model Number: 1R109LPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 50 YR
• Patient Sex: Male