BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    MDR report key: 2992229 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02088
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION 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. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2013-02089, 2210968-2013-02090, AND 2210968-2013-02091. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SUTURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE PULLED OFF THE SUTURE. THE CASE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97411 MONOCRYL PLUS ANTIBACTERIAL SUTURES SUTURES, ABSORBABLE GAM ETHICON, INC. NA EM5DKWV

    Patients

    Seq Age Sex Outcome Treatment
    1