BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5708342 · Received June 9, 2016

    Report

    Report Number
    3002808486-2016-00471
    Event Type
    Injury
    Date Received
    June 9, 2016
    Report Date
    May 26, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP MREYE FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855 OR K032426. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS ALSO BEEN SUBMITTED TO FDA UNDER MANUFACTURER REPORT #3002808486-2016-00436. ALL FUTURE MEDWATCH REPORTS CONCERNING THIS EVENT WILL BE REFERED TO IN MANUFACTURER REPORT #3002808486-2016-00436. MANUFACTURER REPORT#3002808486-2016-00437, MANUFACTURER REPORT#3002808486-2016-00471 WILL BE CLOSED/CANCELLED, AS PATIENT DID NOT RECEIVE THE DESCRIBED DEVICE. (B)(4). DATE OF EVENT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP MREYE FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855 OR K032426. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER, COOK CELECT FILTER, AND GUNTHER TULIP MREYE FILTER IN 2010 AT THE (B)(6) MEDICAL CENTER IN (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER, COOK CELECT FILTER, AND GUNTHER TULIP MREYE FILTER IN 2010 AT THE (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363882 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening