BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOOP LIGATURE WITH PDS II

    MDR report key: 3254053 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15048
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MEDWATCH REPORT 2210968-2013-15048 IS BEING VOIDED AS IT DOES NOT MEET SERIOUS INJURY OR MALFUNCTION REPORTABILITY CRITERIA. THIS EVENT IS THEREFORE NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. WHEN DISPENSING THE PRODUCT THE SUTURE WAS NOT ATTACHED TO THE BREAK POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355719 ENDOLOOP LIGATURE WITH PDS II SUTURE, ABSORBABLE NEW ETHICON INC. UNK DGS683

    Patients

    Seq Age Sex Outcome Treatment
    1