BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER INSERTION TRAY KIT

    MDR report key: 2253868 · Received August 11, 2011

    Report

    Report Number
    1450943-2011-00010
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    March 1, 2010
    Report Date
    March 5, 2010
    Manufacturer
    MEDIKMARK INC.
    Product Code
    FCM
    PMA / PMN Number
    K901185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    END USER ALLEGES THAT TWO 2000CC DRAINAGE BAG LEAKED. MFR MEDIKMARK SELLS TO CUSTOMER (B)(6) THE FOLLOWING KITS: FOLEY CATHETER INSERTION TRAY MEDICAL KITS. THESE KIDS INCLUDE SEVERAL DEVICES, INCLUDING DRAINAGE BAGS. THE BAGS ARE MANUFACTURED AND PROVIDED BY CUSTOMER; I.E., (B)(6) MANUFACTURES AND SHIPS TO MEDIKMARK THE BAGS TO BE INCLUDED IN THE KITS, AND THEN MEDIKMARK SHIPS THE FINISHED KITS AND THE BAGS BACK TO (B)(6). (B)(6) CONTACTED MEDIKMARK TO LET MEDIKMARK KNOW THAT (B)(6) HAD REC'D COMPLAINTS ABOUT LEAKING BAGS FROM (B)(6) CUSTOMER PONTE VEDRA PLASTIC SURGERY. (B)(6) DID NOT HAVE ANY SAMPLE DEVICES RETURNED. (B)(6) REQUESTED MEDIKMARK CONDUCT A DHR REVIEW AND PROVIDE (B)(6) WITH LOT #. MEDIKMARK REVIEWED DHR; REVIEW SHOWED NO ISSUES DURING KIT ASSEMBLY. MEDIKMARK REVIEWED COMPLAINT FILE FOR PAST TWO YEARS; NO COMPLAINTS OF THIS NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER INSERTION TRAY KIT FOLEY CATHETER INSERTION TRAY KIT FCM MEDIKMARK INC. 20090305 / 96035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK