BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERSILENE TAPE

    MDR report key: 7004707 · Received November 6, 2017

    Report

    Report Number
    2210968-2017-70812
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 9, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PROCEDURE NAME, EVENT DATE. DID ANY NEEDLE PIECE FALL IN THE PATIENT¿S BODY? WAS THE NEEDLE FULLY RETRIEVED? X-RAYS TAKEN? RESULTS? WAS NEEDLE REMOVED FROM THE PATIENT? IF YES, DURING SAME PROCEDURE? ANY ADDITIONAL TISSUE DISSECTION DAMAGE DUE TO SEARCHING FOR NEEDLE? ANY OTHER PATIENT CONSEQUENCES? IF YES, WHAT MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. IF NEEDLE PIECE IS STILL RETAINED PLEASE PROVIDE SIZE AND LOCATION.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). ACTUAL DEVICE RETURNED. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. THIS WAS A DUCTILE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781861 MERSILENE TAPE INSTRUMENT, SURGICAL, DISPOSABLE. KDC ETHICON INC. LBP663

    Patients

    Seq Age Sex Outcome Treatment
    1