BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGN S URETHRAL SUPPORT SYSTEM

    MDR report key: 2772209 · Received October 2, 2012

    Report

    Report Number
    1018233-2012-01440
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BARD SHANNON LTD.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED WITHIN THE ORIGINAL UNIT PACKAGING. VISUAL EXAMINATION NOTED THAT THE (B)(4) LID HAD BEEN COMPLETELY REMOVED FROM THE TRAY. (B)(4) TO TRAY TRANSFER APPEARS TO BE SUFFICIENT WITH NO SIGNS OF GAPS, CHANNELS, OR OTHER CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE LABELING AND INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE ALIGN URETHRAL SUPPORT SYSTEM IS INTENDED AS A SINGLE-USE, DISPOSABLE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THE ALIGN URETHRAL SUPPORT SYSTEM. THE DEVICE IS TERMINALLY STERILIZED BY ETHYLENE OXIDE. THE ALIGN URETHRAL SUPPORT SYSTEM IS SUPPLIED AS A COMPLETE OPERATIVE KIT CONSISTING OF TWO STAINLESS STEEL RETROPUBIC AND/OR SUPRAPUBIC INTRODUCERS AND A POLYPROPYLENE MESH IMPLANT SLING ENCASED IN A PROTECTIVE SHEATH WITH GREEN GUIDE TUBES AND CONNECTORS AT EACH END. STORAGE: STORE AT AMBIENT TEMPERATURE. DO NOT USE THE DEVICE PAST THE LAST DAY OF THE LABELED MONTH OF EXPIRATION. UPON RECEIPT OF SHIPMENT, ENSURE THAT THE PACKAGING IS NOT OPEN OR DAMAGED AND RETAINS ITS SEALED INTEGRITY. DO NOT USE THE DEVICE IF THE INTEGRITY OF THE PACKAGING APPEARS COMPROMISED.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE SLING WAS LOOSE, THE STERILE COVER WAS OFF AND UNATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN S URETHRAL SUPPORT SYSTEM FTL BARD SHANNON LTD. NA HUVF0820

    Patients

    Seq Age Sex Outcome Treatment
    1