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

Model Number 1R1210C

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 04/14/2022

Event Type  Injury  

Event Description

Customer claims that leak in cushion resulted in a pressure injury.Customer says he went to the doctor but was not hospitalized.Customer claimed he discovered injury on (b)(6) 2022 and was treated on (b)(6) 2022.

Manufacturer Narrative

The customer stated he has a pressure injury due to cushion going flat, but roho, inc.Has not seen medical records to confirm this.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 failed to respond.

• 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: 14521188
• MDR Text Key: 292789060
• Report Number: 3008630266-2022-00002
• Device Sequence Number: 1
• Product Code: KIC
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1R1210C
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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): Hospitalization; Other
• Patient Sex: Male