MAUDE Adverse Event Report: ROHO, Inc. ROHO High Profile Single Compartment Cushion with Sensor Ready Technology; Wheelchair Cushion

Model Number	1R89H-CA-SR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: ROHO High Profile Single Compartment Cushion with Sensor Ready Technology
• 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 ; +1(618)541-2901
• MDR Report Key: 50262046
• Report Number: 3008630266-2026-00006
• Device Sequence Number: 18675925
• Product Code: KIC
• UDI-Device Identifier: 00613732088002
• UDI-Public: (01)00613732088002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: 1R89H-CA-SR
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 150 LB