BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRELUDE PRO SHEATH INTRODUCER

    MDR report key: 1493626 · Received October 5, 2009

    Report

    Report Number
    1721504-2009-00124
    Event Type
    Other
    Date Received
    October 5, 2009
    Date of Event
    September 25, 2009
    Report Date
    September 28, 2009
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    Removal / Correction Number
    1721504-10/13/09-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MERIT IS RECALLING PRODUCTS OF A SPECIFIC SHIPMENT DUE TO A POTENTIAL STERILITY BREACH WHICH MAY HAVE BEEN CAUSED BY EXCESSIVE SHIPMENT DAMAGE. A DELIVERY TRUCK TRANSPORTING THE PRODUCTS WAS INVOLVED IN A ROLL-OVER ACCIDENT; NEVERTHELESS, THE DELIVERIES WERE MADE WITHOUT MERIT'S CONSENT. DEVICE EVALUATION: THE DEVICE PACKAGING WILL BE INSPECTED IF RETURNED. IF THE PRODUCT WAS USED AND RETURNED, IT WILL BE EVALUATED. EVALUATION CODES, CONCLUSIONS: IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED TO FDA IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    REASON FOR PRODUCT RECALL: MERIT MEDICAL SYSTEMS, INC. IS RECALLING A SPECIFIC SHIPMENT OF PRODUCTS DUE TO POTENTIAL STERILITY BREACH WHICH MAY HAVE BEEN CAUSED BY EXCESSIVE SHIPMENT DAMAGE. PLEASE NOTE THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRELUDE PRO SHEATH INTRODUCER DILATOR, VESSEL, FOR PERCUTANEOUS CATH. DRE MERIT MEDICAL SYSTEMS, INC. NA F712835

    Patients

    Seq Age Sex Outcome Treatment
    1