BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3843836 · Received June 2, 2014

    Report

    Report Number
    2210968-2014-06940
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. UPON VISUAL AND FUNCTION EVALUATION, THE SAMPLES SATISFIED REQUIREMENTS. 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 THE PATIENT UNDERWENT A UROLOGY SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. AFTER A COUPLE OF PASSES OF THE NEEDLE, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321325 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GL8GXGA0

    Patients

    Seq Age Sex Outcome Treatment
    1