BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3170079 · Received June 5, 2013

    Report

    Report Number
    1820334-2013-00257
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    June 23, 2010
    Report Date
    May 10, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT - PROVIDED LOT (3004082) DOES NOT MATCH ANYTHING IN COOKS' SYSTEM. CATALOG # - UNK AS NOT PROVIDED BY REPORTER AND NOT CONFIRMED BY A COOK PRODUCT. EXPIRATION - UNK AS PROVIDED LOT IS INCORRECT. (B)(4): PROBLEMS WITH LIMBS IS UNK TO BE LABELED AS CATALOG NUMBER WAS NOT PROVIDED. (B)(4) - IT IS UNK WHAT PROBLEM WITH A COOK DEVICE IS ALLEGED AS INCORRECT LOT AND NO CATALOG NUMBER HAVE BEEN PROVIDED.EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COUNSEL FOR POTENTIAL CLAIMANT ALLEGES IN HER LETTER TO COOK THAT HER CLIENT HAS EXPERIENCED PROBLEMS WITH HER RIGHT UPPER LIMB SINCE UNDERGOING A FEMORAL ANGIOGRAM ON (B)(6) 2010. CLAIMANT ALLEGES A 6 FR ANGIOGRAM SHEATH USED DURING HER PROCEDURE IS RESPONSIBLE FOR HER "CONSTANT PAIN." THE LOT NUMBER PROVIDED, HOWEVER, DOES NOT MATCH ANY OF COOK'S RECORDS AND THEREFORE THE ACTUAL CATALOG NUMBER COULD NOT BE DETERMINED. CLAIMANT'S COUNSEL IS GOING TO FOLLOW-UP WITH THE HOSPITAL AND REPORT BACK IF A DIFFERENT LOT NUMBER IS LOCATED. THERE IS NO INFO TO DETERMINE WITH CERTAINTY THAT A COOK DEVICE WAS INVOLVED AND THUS AN INVESTIGATION CANNOT BE COMPLETED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249376 UNKNOWN NONE DYB COOK, INC. NA 3004082-INCORRECT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other