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

Model Number	1R1110C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer claims that he developed a pressure sore due to cushion going flat but roho, inc.Has not seen medical records to confirm this.The manufacturing records were reviewed and indicated the cushion passed all inspections and verifications.The cushion was returned and a product evaluation was performed, which identified cushion creasing with probable cause due to improper product maintenance.The complaint for the cushion was received on 10/04/2022, but roho, inc.Was not made aware of alleged injury until 01/17/2023.During this lapse in time, the cushion was disposed of.As a result, a full evaluation report could not be completed on cushion.Cushion operation manual contains safety information related to checking skin frequently for redness or bruising and instructions to check inflation that reads: "check skin frequently, at least once a day.Redness, bruising, or darker areas (when compared to normal skin) may indicate superficial or deep tissue injury and should be addressed.If there is any discoloration to skin/soft tissue, stop use immediately.If the discoloration does not disappear within 30 minutes after disuse, immediately consult a healthcare professional.Check inflation frequently, at least once a day.Do not use a product that is underinflated or overinflated, because 1) the product benefits will be reduced or eliminated, resulting in an increased risk to skin and other soft tissue".If additional information is received, a follow-up report will be submitted.
Event or Problem Description
Customer stated that a pressure injury developed because cushion was going flat.

• Brand Name: ROHO HIGH PROFILE SINGLE COMPARTMENT 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: cynthia jackson ; 1501 s 74th st; belleville, IL 62223 ; 6182223542
• MDR Report Key: 16328452
• Report Number: 3008630266-2023-00001
• Device Sequence Number: 7828298
• Product Code: KIC
• UDI-Device Identifier: 00613732005580
• UDI-Public: (01)00613732005580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/09/2023

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: 1R1110C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG