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

Model Number	1R109C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During investigation, the returned cushion appeared well worn and heavily soiled.The valve was confirmed to be missing and was not returned with the cushion.An attempt had been made by the user or users caregiver to plug the valve stem with a foreign material to prevent it from leaking.The barbed valves are able to be removed from the valve stem tubing when pulling with a reasonable amount of force.Acceptance levels in manufacturing is minimum 10 pounds force to remove the valve.Removal of the valve from the tubing would be an obvious event, the cushion would not be able to hold air.The most likely cause to the reported failure is the user or her caregiver pulled the valve from the tubing, possibly during inflation, and did not replace the valve.The ifu specifically states to check the cushion for proper inflation with each use and to discontinue use if the cushion is improperly inflated.The users cushion was replaced under warranty with a new cushion.
Event or Problem Description
User reported the end of the valve was missing.User stated she keeps getting pressure ulcers but state "won't say that the cushion caused the ulcers".The user has been placed on bedrest, the improperly inflated cushion exacerbated her existing pressure injury.The cushion was returned to roho and verified to have a missing valve on (b)(6) 2025.

• Brand Name: ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION
• Common Device Name: CUSHION, WHEELCHAIR
• Manufacturer (Section D): ROHO, INC.,; 1501 s. 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer Contact: steven louer ; 1501 s. 74th st.; belleville, IL 62223 ; 6185412901
• MDR Report Key: 21853096
• Report Number: 3008630266-2025-00001
• Device Sequence Number: 8608238
• Product Code: IMP
• UDI-Device Identifier: 00613732005481
• UDI-Public: (01)00613732005481
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/16/2025

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: 1R109C
• Device Catalogue Number: 1R109C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female