BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1031968 · Received April 18, 2008

    Report

    Report Number
    2210968-2008-00267
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE NEEDLE BROKE DURING A GYNECOLOGICAL PROCEDURE. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA ZK8HPZP0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK