BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3242948 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14184
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHILE THE SURGEON WAS CLOSING THE FASCIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344150 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GB8BDJQ0

    Patients

    Seq Age Sex Outcome Treatment
    1