BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER WOVEN TAPE

    MDR report key: 6094281 · Received November 10, 2016

    Report

    Report Number
    2210968-2016-14869
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 24, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2016 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. THE DOCTOR WAS UNABLE TO LOCATE THE BROKEN TIP, EITHER IN OR OUTSIDE OF THE PATIENT. MAGNETS WERE USED TO FIND THE TIP, BUT NO SUCCESS. THE DOCTOR OPTED NOT TO USE X-RAY TO LOCATE THE TIP BECAUSE THE PATIENT WAS PREGANANT AT THE TIME OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745851 MERSILENE POLYESTER WOVEN TAPE CLASS I DEVICE - EXEMPT KDC ETHICON INC. UNK GBB902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other