BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3201840 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11881
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.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): 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 A PANHYSTERECTOMY PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED ON THE VAGINAL STUMP WITH Z-TECHNIQUE. WHEN THE SURGEON TRIED TO PULL THE NEEDLE OUT THROUGH THE TISSUE, THE SUTURE EASILY DETACHED FROM THE NEEDLE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301100 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK EL2107

    Patients

    Seq Age Sex Outcome Treatment
    1