BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 1062466 · Received June 17, 2008

    Report

    Report Number
    2210968-2008-00452
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 19, 2008
    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

    DATE SENT TO THE FDA: 06/17/2008. RESULT: REPRESENTATIVE SAMPLES OF THE REPORTED LOT WERE VISUALLY EXAMINED WHEN TESTED FOR NEEDLE STRENGTH AND DUCTILITY. NO VISUAL NON-CONFORMANCES WERE IDENTIFIED. THE RESULTS MET REQUIREMENTS. CONCLUSION: NO FAILURE DETECTED AND THE PRODUCT MET STRENGTH AND DUCTILITY REQUIREMENTS. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE NEEDLE BROKE DURING AN EPISIOTOMY REPAIR. THE PATIENT WAS TRANSFERRED TO THE OR FOR SURGICAL EXCISION OF A RETAINED NEEDLE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA XK2BBKM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention