BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARADY VARIX EXTRACTOR W/HOOK 180MM

    MDR report key: 4617965 · Received March 4, 2015

    Report

    Report Number
    2916714-2015-00179
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Report Date
    March 4, 2015
    Manufacturer
    AESCULAP AP & CO. KG
    Product Code
    GAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVAL: MATERIAL AND HARDNESS TEST RESULTS INDICATE PRODUCT IS W/IN SPEC. THE BREAK IS A SPONTANEOUS FORCE FRACTURE; MECHANICAL OVERLOAD. NO PRODUCT DEVIATIONS FOUND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). VARADY HOOK TIP BROKE. FRAGMENT (STERILE AND BLUNT) LEFT IN PT, FOUND ON X-RAY AFTER SURGERY. SURGEON AND PT ARE SATISFIED W/RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149651 VARADY VARIX EXTRACTOR W/HOOK 180MM VEIN STRIPPER GAI AESCULAP AP & CO. KG FB121R

    Patients

    Seq Age Sex Outcome Treatment
    1