BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 2842983 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07392
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED FOR ANALYSIS. THE PACKAGING DAMAGE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ABSOLUTE PRO STENT BOX WAS BEING UNPACKED AT THE ABBOTT AFFILIATE WAREHOUSE WHEN THE STAFF NOTICED THAT THERE WAS A HOLE IN THE SIDE OF THE BOX. THIS PRODUCT IS BEING RETURNED BECAUSE THE OUTER BOX IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND THE HOLE WAS FOUND WHEN UNPACKING THE SHIPMENT AT THE ABBOTT WAREHOUSE AFTER BEING RETURNED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 2012861

    Patients

    Seq Age Sex Outcome Treatment
    1