BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3800688 · Received May 8, 2014

    Report

    Report Number
    2210968-2014-05921
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS AN UMBILICUS APROX. THE BROKEN NEEDLE PIECE WAS VISIBLE AND RETRIEVED AT THAT MOMENT. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    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). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278681 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK 476824

    Patients

    Seq Age Sex Outcome Treatment
    1