MAUDE Adverse Event Report: ROHO, INC. ROHO, INC.; WHEELCHAIR CUSHION

Model Number	QS1112MPC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 6/26/2025, dealer ability medical supply, inc reported a warranty complaint to roho customer experience representative that their client (b)(6) had a roho cushion model qslgmpc.The representative from ability medical supply stated the clients cushion was no longer holding air in the left rear quadrant of the cushion.The representative stated that he was unable to identify how the cushion was losing air.He stated the client had developed a pressure sore on their buttock in the location of the deflated cushion.A warranty replacement was entered for the defective cushion.
Additional Manufacturer Narrative
The distributor was provided a replacement cushion under warranty and requested to return the reported cushion to roho for investigation.As of the time of this report, the return cushion has not been received by roho.Updated investigation will be provided should the cushion be received for evaluation.Manufacturing records indicate the cushion passed all inspections and verifications.

• Brand Name: ROHO, INC.
• Common Device Name: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th st.; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th st.; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 22620733
• Report Number: 3008630266-2025-00004
• Device Sequence Number: 10118710
• Product Code: KIC
• UDI-Device Identifier: 00613732091880
• UDI-Public: (01)00613732091880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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 Model Number: QS1112MPC
• Device Catalogue Number: QS1112MPC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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: 49 YR
• Patient Sex: Male