BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1191085 · Received September 24, 2008

    Report

    Report Number
    2210968-2008-00880
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K946271
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A NEEDLE BROKE DURING A CESAREAN SECTION. TWO-THIRDS OF THE NEEDLE REMAINS EMBEDDED WITHIN THE UTERINE WALL. IT IS NOT KNOWN AT THIS TIME IF THERE ARE PLANS TO EXPLANT THE RETAINED FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AC7048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK