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

Model Number 1R77C

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 12/25/2022

Event Type  Injury  

Manufacturer Narrative

The customer alleged that a pressure injury worsened due to cushion going flat, but roho, inc.Has not seen medical records to confirm this.The manufacturing records were reviewed and indicates the cushion passed all inspections and verifications.It is unclear if product malfunction caused or contributed to the pressure wound.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 cushion was not returned to roho, inc.So an evaluation could not be performed.Roho, inc, contacted the customer for more information regarding the alleged failure of the cushion, but the customer has not responded.If new information is received, we will submit a follow up report.

Event Description

Customer claims existing pressure sore worsened due to cushion going flat.

• Brand Name: ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION
• Type of Device: 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: 16371416
• MDR Text Key: 309481926
• Report Number: 3008630266-2023-00002
• Device Sequence Number: 1
• Product Code: KIC
• UDI-Device Identifier: 00613732005825
• UDI-Public: (01)00613732005825
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1R77C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male