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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROHO, INC. ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION; WHEELCHAIR CUSHION
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ROHO, INC. ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION; WHEELCHAIR CUSHION Back to Search Results
Model Number 1R1011C
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem Tissue Breakdown (2681)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Roho, inc was notified of an alleged injury on (b)(6) 2019 and an investigation was initiated.Since the initial notification, several attempts have been made to contact the customer including; a mailed letter and nine phone calls.No responses were received following any attempt, and an email address was not provided by the customer.The report of an injury allegation has been documented; however, we are unable to access medical records or reach the customer for confirmation.At initial contact, the end user stated that a piece of their inflation valve was lodged inside of their inflation pump.Due to this, the end user mentioned that they were unable to inflate their cushion for 5 days, during which, their care representative was not available.Upon the care representative's return, it was alleged that the end user's skin was beginning to breakdown due to them using a deflated cushion for the previous 5 days.A request was made by the manufacturer that the cushion along with the pump be returned, due to the inflation valve being designed too large to fit completely into the inflation pump.The customer was sent a replacement cushion, but at this time, the original cushion and pump have not been returned.If additional information is received, a follow-up report will be submitted.
 
Event Description
Per end user and their care representative- the end user has been on a flat cushion for 5 days and "his bottom is starting to breakdown".
 
Manufacturer Narrative
Roho, inc was notified of an alleged injury on (b)(6) 2019 and an investigation was initiated.Since the initial notification, several attempts have been made to contact the customer including; a mailed letter and nine phone calls.No responses were received following any attempt, and an email address was not provided by the customer.The report of an injury allegation has been documented; however, we are unable to access medical records or reach the customer for confirmation.At initial contact, the end user stated that a piece of their inflation valve was lodged inside of their inflation pump.Due to this, the end user mentioned that they were unable to inflate their cushion for 5 days, during which, their care representative was not available.Upon the care representative's return, it was alleged that the end user's skin was beginning to breakdown due to them using a deflated cushion for the previous 5 days.A request was made by the manufacturer that the cushion along with the pump be returned, due to the inflation valve being designed too large to fit completely into the inflation pump.The customer was sent a replacement cushion, but at this time, the original cushion and pump have not been returned.If additional information is received, a follow-up report will be submitted.Update- on february 05th, 2020 a 45 day response letter was received from the fda requesting additional information regarding this complaint and one other.Response was drafted and submitted within the proper timeframe.An evaluation was also completed on the device.A copy of the evaluation report will be attached.
 
Event Description
Per end user and their care representative- the end user has been on a flat cushion for 5 days and "his bottom is starting to breakdown".
 
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Brand Name
ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION
Type of Device
WHEELCHAIR CUSHION
Manufacturer (Section D)
ROHO, INC.
1501 s. 74th street
belleville IL 62223
MDR Report Key8950803
MDR Text Key156136323
Report Number1419507-2019-00004
Device Sequence Number1
Product Code KIC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number1R1011C
Was Device Available for Evaluation? No
Date Manufacturer Received08/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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