BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO AGILITY CARBON MID CONTOUR BACK SUPPORT

    MDR report key: 11772723 · Received May 4, 2021

    Report

    Report Number
    3008630266-2021-00008
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    February 5, 2021
    Report Date
    April 5, 2021
    Manufacturer
    ROHO, INC
    Product Code
    KNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROHO, INC, RECEIVED NOTIFICATION OF THE ADVERSE EVENT THROUGH A LETTER FROM A LAW FIRM. THE FULL EXTENT OF THE INJURIES ARE UNKNOWN. PICTURES OF THE BACK SUPPORT WERE RECEIVED SHOWING THAT A BOLT BROKE, BUT THE BACK SUPPORT HAS NOT BEEN RETURNED TO ROHO, INC. FOR AN EVALUATION. NO DETERMINATION OF THE ALLEGED FAILURE CAN BE MADE. THE FINAL ACCEPTANCE RECORDS FOR THE CUSHION WERE REVIEWED AND IT WAS CONFIRMED THAT THE BACK SUPPORT WAS BUILT ACCORDING TO THE DEVICE MASTER RECORD. FURTHER REQUESTS FOR INFORMATION HAS BEEN SUBMITTED TO THE LAW FIRM AND IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER ALLEGES THAT DURING NORMAL USE THE BACK REST SNAPPED BACKWARDS CAUSING THE USER TO TIP OVER BACKWARDS AND KNEE HIMSELF IN THE FACE, BREAKING HIS NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666124 ROHO AGILITY CARBON MID CONTOUR BACK SUPPORT WHEELCHAIR BACK SUPPORT KNO ROHO, INC AG3-1710A-2TCB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other