BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 3800781 · Received May 8, 2014

    Report

    Report Number
    2210968-2014-02276
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 24, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. IN ADDITION, 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 AN EPISIOTOMY ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BROKE. IT IS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO HAVE THE NEEDLE FRAGMENT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278923 VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GE8BPZZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other