BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 1040144 · Received May 6, 2008

    Report

    Report Number
    2210968-2008-00334
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE TIP OF THE DRAIN REMAINED WITHIN THE SURGICAL WOUND FOLLOWING REMOVAL OF THE ARTHROSCOPIC TROCAR. THE SURGEON OPINES THAT THE TROCAR CUT THE TIP DURING PLACEMENT. THE TIP WAS RETRIEVED DURING THE INITIAL SURGERY WITH NO FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA 47065ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR