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

Model Number	CS1211C
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The dealer reported their user has a contour select cushion which the user has complained continues to deflate.The dealer has visited the user several times and the cushion appeared to inflate properly at each visit.After their visit the right front quadrant of the cushion deflates.The dealer has been unable to identify a leak but the use has developed a pressure wound on his buttox which has required daily visits by wound care for healing.
Additional Manufacturer Narrative
Inspection of the cushion was performed on 01/22/2026 after return.A tear was found between two cells which was producing a slow leak.The tear was located at the base between two cells making it difficult to see.The tear was located in a position in which the back of the cushion is glued to the cellular surface of the cushion.Every cushion is inspected several times through the manufacturing process.One of the final steps of the assembly process is to over-inflate the cushion and hold them overnight.Final inspection of the over inflated cushions are performed to ensure the cushion has not deflated during the holding period to ensure no unobserved leaks are present.The manufacturing records were reviewed and there is no indication that this process identified any defects.Tears such as the one observed in this investigation are caused by a pulling/shearing process.These tears are observed during the manufacturing process during the steps up to assembly and are culled out at all stages of the manufacturing process.These tears have also been observed after delivery by shearing forces on the cushion such as pulling the cushion by a cell, carrying the cushion by the cells, improper transfer technique etc.Roho was unable to rule out the possibility that this tear was present prior to assembly of the cushion.The location of the tear could have allowed the glued surface to seal the tear from leaking, masking it during the final inspection process.This is considered an isolated incident and no further corrective actions have been identified to the manufacturing process.

• Brand Name: ROHO CONTOUR SELECT CUSHION
• 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
• MDR Report Key: 24230087
• Report Number: 3008630266-2026-00002
• Device Sequence Number: 13066500
• Product Code: KIC
• UDI-Device Identifier: 00613732077303
• UDI-Public: (01)00613732077303
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/31/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CS1211C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male