MAUDE Adverse Event Report: ROHO, INC. ROHO MOSAIC CUSHION; WHEELCHAIR CUSHION

Model Number MOS2018CA

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The enduser stated that he had an existing pressure injury that worsened due to the performance of the cushion, 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 was not willing to provide further details.

Event Description

Mr (b)(6) claims that due to the lack of performance of our product he has sores to where he can only stand.He was unsure of the exact date of alleged injury, claims that he has been dealing with the issue for several weeks.

• Brand Name: ROHO MOSAIC CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 south 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 south 74th street; belleville IL 62223
• Manufacturer Contact: robin gergen ; 1501 south 74th street; belleville, IL 62223
• MDR Report Key: 12355556
• MDR Text Key: 267736471
• Report Number: 3008630266-2021-00011
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MOS2018CA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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