BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V MUELLER VASCULAR LOOPS MINI RED STRL

    MDR report key: 5709738 · Received June 9, 2016

    Report

    Report Number
    1423507-2016-00060
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    May 9, 2016
    Report Date
    June 9, 2016
    Manufacturer
    IBC (INTERNATIONAL BIOPHYSICS CORP)
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ON 10MAY2016 CUSTOMER ADVOCACY SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT NUMBER, AND INQUIRING IF ADDITIONAL INFORMATION MAY BE AVAILABLE. CONFIRMATION WAS ALSO REQUESTED FROM THE CUSTOMER THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH REPORTED ISSUE. ON 23MAY2016 THE COMPLAINT WAS CLOSED, AND ON 31MAY2016 THE CUSTOMER SENT ADDITIONAL INFORMATION. DEVICE WAS EVALUATED BY THE MANUFACTURER AND IT COULD NOT CONFIRM THE REPORTED ISSUE. BASED UPON THE TESTING PERFORMED, ALL PRODUCTS PERFORMED AS EXPECTED THERE WERE NO DEFECTS NOTED. NO ROOT CAUSE COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    SALES REP REPORTED VIA EMAIL THE PRODUCT IS STRETCHING LIKE RUBBER BANDS. ON 31MAY2016 ADDITIONAL INFORMATION: WAS THE PRODUCT RECEIVED IN THIS CONDITION? YES. IF NOT, WHAT WAS THE PRODUCT BEING USED FOR WHEN IT WAS OBSERVED THAT PRODUCT IS STRETCHING LIKE RUBBER BANDS? THESE ARE USED ON CAROTIDS AND ENDOVASCULAR STENT CASES. PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. YES, NUMEROUS DOCTORS HAD TROUBLE CONTROLLING THE BLEEDING AND HAD TO USE CLAMPS INSTEAD. DO YOU HAVE THE LOT#? WERE SENT IN BUT ALL PRODUCT ON OUR SHELVES ARE NOT SAFE FOR USE. THE NEW LIGA-LOOPS APPEAR TO BE MADE FROM PLASTIC MATERIAL WITH MINIMAL ELASTICITY. THE PLASTIC JUST STRETCHES AND DOES NOT CONSTRICT TO CONTROL THE BLEEDING. BOTH CASES THE SURGEONS HAD BLOOD BATHS DURING THE PROCEDURES WHICH ULTIMATELY AFFECT THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365133 V MUELLER VASCULAR LOOPS MINI RED STRL INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS IBC (INTERNATIONAL BIOPHYSICS CORP) CH115 111115-3864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other