BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 1964786 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01742
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE NEEDLE BROKE IN TWO PARTS DURING USE. ONE PIECE STAYED ON THE SUTURE, WHILE THE OTHER PART WAS RETRIEVED FROM THE TISSUE OF THE PT. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA BJ2BBPM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK