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

Model Number ENHLGC

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

In response to the allegations of the end user's husband, the product was requested back for an evaluation.Upon receipt, it was determined that a base hole was present between two cells of the cushion.No additional irregularities were observed.Per report submitted by end user, the observations documented during the evaluation are consistent with the presenting concern.The end user described an increased amount of pressure on the lateral side of both his wife's thighs.Based on the findings, this would occur due to the cushion being improperly inflated.The improper inflation due to the base hole, placed additional pressure via the side air cells against the end user vs.The pressure being evenly distributed across the cushion.The end user is still in the process of recovery but is reported as being stabilized and doing well.It was reported by the end user's husband that the cushion was continuously used even with it being visually under-inflated, which is contrary to the safety information in the instructions for use.Currently, the replacement cushion that the end user received has been confirmed as functioning properly and without incident.Although an alleged injury has been reported, no medical documents have been submitted for confirmation.If additional information is received, a follow-up report will be submitted.

Event Description

End users husband claims that his wife received pressure injuries on the lateral side of both thighs from her cushion.

• Brand Name: ROHO® ENHANCER® 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: 9241770
• MDR Text Key: 165564616
• Report Number: 1419507-2019-00006
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ENHLGC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2019
• 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