BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    MDR report key: 4351171 · Received December 12, 2014

    Report

    Report Number
    2916714-2014-01009
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    June 26, 2014
    Report Date
    December 10, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K111824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. K111824/ K130596. PRODUCT WAS NOT RETURNED FOR EVAL. THE MFG DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS DURING THE TIME OF PRODUCTION. THERE ARE CURRENTLY NO FURTHER COMPLAINTS WITH LOT # 52027283.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INSUFFICIENT COAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818748 CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG AND CO. KG PL720SU 52027283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other