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

Model Number 1R77H-CA-SR

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

The end user reached out to the manufacturer on (b)(6), stating that they were having difficulties inflating their cushion.The end user was provided instructions for inflation, and referred to a local distributor, should further assistance be needed as they were travelling out of the country.The end user reached out again on (b)(6) alleging an injury.Per local distributor representative (that maintained contact with the end user)- the end user had been attempting to use the "sensor ready" valve instead of the inflation valve to inflate the cushion.It is believed by the end user, that after sitting on the cushion for 33 hours while travelling on a flight-with it never being inflated properly is what caused the alleged injury.The local distributor has remained onsite assisting the end user with recovery from their reported hospitalization and provided the end user with a manufacturer replacement cushion, which they properly set-up.The end user is still in the process of recovery but has vocalized immense satisfaction with both the manufacturer and the local distributor for their assistance as he remains out of the country until recovered enough to travel.This incident is categorized as a device use error seeing as how the end user unknowingly utilized the incorrect valve for inflation.At this time, no additional information is available, but should additional information be received, a follow-up report will be submitted.

Event Description

Per end user's e-mail- "i emailed you (b)(6) 2019 and you transferred to xxxxxxxx xx xxxxx to repair.They have no idea about the new valve.I called you but no one answered.I'm in the hospital and i can't get back to usa because i have a big and deep wound.It's urgent you send me a new cushion with or without new or old valve.I'm completely paralyzed and i used roho for more than 20 years and i had a problem.I never can open the new valve and the instructions are so bad and basic.Is not easy like turned left and right or this one doesn't work".

• Brand Name: ROHO® HIGH PROFILE® SINGLE COMPARTMENT CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer Contact: robin gergen ; 1501 s. 74th street; belleville, IL 62223 ; 8008513449
• MDR Report Key: 8824063
• MDR Text Key: 152118490
• Report Number: 1419507-2019-00003
• Device Sequence Number: 1
• Product Code: KIC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1R77H-CA-SR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other