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

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The documentation from the end user's legal representation claimed severe and permanent injuries, but roho, inc.Has not seen medical records to confirm this.No device identification was provided, so a review of the manufacturing records was not possible.If any additional information is made available, a follow up report will be submitted.

Event Description

Received litigation documentation stating the end user suffered "severe and permanent injuries, including but not limited to, chronic buttocks and sacral pressure injuries; as well as aches, pains, mental anxiety and anguish, and a sever shock to his entire nervous system.".

• 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: robin gergen ; 1501 s. 74th st.; belleville, IL 62223 ; 6182228363
• MDR Report Key: 14656498
• MDR Text Key: 294784164
• Report Number: 3008630266-2022-00004
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• 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: Male