BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2770821 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-05759
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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

    NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE AFTER TWO TISSUE PASSES. THE SURGEON CHANGED TO ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA EE2302

    Patients

    Seq Age Sex Outcome Treatment
    1