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

Model Number	1R1010C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer claims that he developed a pressure wound due to cushion going flat.
Additional Manufacturer Narrative
Customer claims that he developed a stage 4 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.It is unclear if product malfunction caused or contributed to the pressure wound as the product was not returned for evaluation.The user has warning in the manual to discontinue use of a defective product that reads as follows: "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" the user is hospitalized due to unrelated illness and is unable to return cushion to roho, inc at this time.Therefore, a product evaluation could not be performed.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: 16731849
• Report Number: 3008630266-2023-00005
• Device Sequence Number: 12478185
• Product Code: KIC
• UDI-Device Identifier: 00613732005245
• UDI-Public: (01)00613732005245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/12/2023

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: 1R1010C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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: 63 YR
• Patient Sex: Male