MAUDE Adverse Event Report: ROHO, INC. ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION; WHEELCHAIR CUSHION

Model Number RQS89

Device Problems Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problem Pressure Sores (2326)

Event Date 12/16/2023

Event Type  Injury  

Manufacturer Narrative

The customer alleged that cushion going flat contributed to pressure injury, 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.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.If new information is received, we will submit a follow up report.

Event Description

Customer claims that flat cushion contributed to pressure injury.

Manufacturer Narrative

The cushion associated with complaint was returned and an evaluation report is attached.Evaluation of the cushion revealed a small laceration likely caused by an exteral force.If new information is received, another follow up report will be submitted.

• Brand Name: ROHO® QUADTRO SELECT® HIGH PROFILE® 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: 18525004
• MDR Text Key: 333023910
• Report Number: 3008630266-2024-00001
• Device Sequence Number: 1
• Product Code: KIC
• UDI-Device Identifier: 00613732054120
• UDI-Public: 0100613732054120
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RQS89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female