BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

    MDR report key: 8122274 · Received December 1, 2018

    Report

    Report Number
    1419507-2018-00005
    Event Type
    Injury
    Date Received
    December 1, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROHO, INC. WAS NOTIFIED OF THE ALLEGED INJURY BY THE CUSTOMER'S LEGAL COUNSEL AND IS UNABLE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. THE SPECIFIC MODEL OF THE DEVICE, SERIAL NUMBER, AND MANUFACTURING DATE ARE UNKNOWN. THEREFORE, WE ARE UNABLE TO REVIEW MANUFACTURING RECORDS FOR THE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED SO WE CANNOT PERFORM AN INVESTIGATION ON THE DEVICE ITSELF. WE'VE REVIEWED OUR EXISTING COMPLAINTS AND FOUND NO OTHER SIMILAR COMPLAINTS ON FILE. IF WE RECEIVE ADDITIONAL INFORMATION, WE WILL SEND A FOLLOW-UP REPORT. THE CUSTOMER CLAIMED THERE WAS AN INJURY. HOWEVER, WE ARE NOT ABLE TO ACCESS MEDICAL RECORDS TO CONFIRM. UPDATE- A DHR REVIEW WAS CONDUCTED ONCE THE SERIAL NUMBER FOR THIS CUSHION WAS RECEIVED. NO ABNORMALITIES/DEVIATIONS WERE FOUND WITH HOW THE CUSHION WAS MANUFACTURED. THERE HAS STILL BEEN NO ADDITIONAL CONTACT WITH THE END USER, AND NO OTHER UPDATES ARE AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT THE INFLATION VALVE ON A ROHO PRODUCT PUNCTURED HIM LEADING TO AN INJURY AND BONE INFECTION THAT REQUIRED TWO SURGERIES.

    Additional Manufacturer Narrative · 1

    ROHO, INC. WAS NOTIFIED OF THE ALLEGED INJURY BY THE CUSTOMER'S LEGAL COUNSEL AND IS UNABLE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. THE SPECIFIC MODEL OF THE DEVICE, SERIAL NUMBER, AND MANUFACTURING DATE ARE UNKNOWN. THEREFORE, WE ARE UNABLE TO REVIEW MANUFACTURING RECORDS FOR THE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED SO WE CANNOT PERFORM AN INVESTIGATION ON THE DEVICE ITSELF. WE'VE REVIEWED OUR EXISTING COMPLAINTS AND FOUND NO OTHER SIMILAR COMPLAINTS ON FILE. IF WE RECEIVE ADDITIONAL INFORMATION, WE WILL SEND A FOLLOW-UP REPORT. THE CUSTOMER CLAIMED THERE WAS AN INJURY. HOWEVER, WE ARE NOT ABLE TO ACCESS MEDICAL RECORDS TO CONFIRM.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE INFLATION VALVE ON A ROHO PRODUCT PUNCTURED HIM LEADING TO AN INJURY AND BONE INFECTION THAT REQUIRED TWO SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961707 ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 1R1011C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O