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

Model Number 1R1111C

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 05/31/2023

Event Type  Injury  

Event Description

Canadian mdpr report submitted to health canada by user facility claiming resident developed pressure injury to lower buttock and dorsal aspect of thigh due to cushion not being properly inflated.

Manufacturer Narrative

User facility submitted mdpr #1055088 to health canada claiming patient developed a pressure injury to lower buttock and dorsal aspect of thigh due to cushion not being properly inflated.Cushion was inflated to proper levels by resident occupational therapist after discovery of injury.Roho, inc.Has not seen medical records confirming injury.It was determined from incident details provided in initial report that the injury inflicted was a result of usage error of the roho cushion.Usage error contributed to cushion not being inflated properly.There was no claim of cushion malfunction.The user has direction in the manual to check cushion inflation frequently and to not use an underinflated cushion 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 facility did not claim product malfunction, therefore the cushion was not returned for evaluation.If additional information is received, a follow-up report will be submitted.

• 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: 17649672
• MDR Text Key: 322259657
• Report Number: 3008630266-2023-00008
• Device Sequence Number: 1
• Product Code: KIC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1R1111C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female