BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP

    MDR report key: 3073187 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04328
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE OPERATED AS INTENDED DURING THE EVALUATION.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND STRAPS WERE USED. AFTER FIRING THE DEVICE FOR THE THIRD TIME, THE SURGEON NOTED THAT A VESSEL WAS NICKED WHICH CAUSED BLEEDING. THE BLEEDING WAS MANAGED BY TAMPONADE WITH GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175608 SECURESTRAP IMPLANTABLE STAPLE GDW ETHICON, INC. NA EMZ064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention