BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOECOVER DURAFIT UNIV SZ ANTISKID

    MDR report key: 7759397 · Received August 7, 2018

    Report

    Report Number
    1423537-2018-00231
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 26, 2018
    Report Date
    August 7, 2018
    Manufacturer
    LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER¿S INVESTIGATION THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT NUMBER WAS NOT PROVIDED. ACCORDING TO THE PRODUCT HISTORY RECORD, THE COF (COEFFICIENT OF FRICTION) FOR THIS PRODUCT MET SPECIFICATIONS. AS A SAMPLE WAS NOT RECEIVED FOR FURTHER INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    A FEMALE STAFF MEMBER (OR TECH) REPORTEDLY SLIPPED AND FELL WHILE WEARING THE SHOE COVERS. SHE WENT TO AN ORTHOPEDIC SURGEON AND HAD SURGERY ON HER SHOULDER DUE TO A TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598357 SHOECOVER DURAFIT UNIV SZ ANTISKID COVER, SHOE, OPERATING-ROOM FXP LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD 4852 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other