BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    MDR report key: 1934053 · Received December 2, 2010

    Report

    Report Number
    2210968-2010-01640
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 16, 2010
    Report Date
    November 1, 2010
    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: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 A PT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE INTO 3 PIECES. THE SURGEON STATED THAT NO REAL PRESSURE WAS PUT ON THE NEEDLE. THEY THINK THEY RECOVERED ALL OF THE PIECES FROM THE PT. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CE8BRSP0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK