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

Model Number	QS1211C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user was provided a replacement cushion 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 and the tracking number has yet to be activated.Updated investigation will be provided should the cushion be received for evaluation.Manufacturing records indicate the cushion passed all inspections and verifications.This includes overinflation of all four quadrants to ensure each quadrant hold air as expected.
Event or Problem Description
Mr.(b)(6) received a new roho cushion.He has been a roho user for several years.Upon the first day of use, one quadrant of the cushion had deflated when he went to get off the cushion at the end of the day.Redness was identified from sitting on the deflated section.Within two days, the redness had worsened to a pressure sore injury, and mr.(b)(6) had to seek treatment from the wound care clinic.A new cushion was provided under the warranty replacement program.

• Brand Name: ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION
• 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: 22398782
• Report Number: 3008630266-2025-00003
• Device Sequence Number: 8639288
• Product Code: KIC
• UDI-Device Identifier: 00613732061210
• UDI-Public: (01)00613732061210
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: QS1211C
• Device Catalogue Number: QS1211C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male