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

Model Number	1R109C
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Cusomer claims that he developed a pressure wound due to cushion going flat.
Additional Manufacturer Narrative
The customer alleged that a pressure injury developed 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 the evaluation report is attached.Evaluation of the cushion revealed rubber rot caused by exposure to ozone or similar cleaning chemical.The user manual instructs against the use of ozone which states: "prolonged exposure to ozone may degrade materials used in the cushion, affect the performance of the cushion, and void the product warranty." the user has warning in the manual to check skin frequently: "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." roho, inc.Attempted to contact customer at hospital which he was admitted, but patient was discharged.Attempts to acquire additional contact information were unsuccessful.If additional information is received, a follow up report will be submitted.

• 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: 16444058
• Report Number: 3008630266-2023-00003
• Device Sequence Number: 5530654
• Product Code: KIC
• UDI-Device Identifier: 00613732005481
• UDI-Public: (01)00613732005481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 02/27/2023

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: 1R109C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male