BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2063478 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00446
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TROCAR SLEEVE DIFFICULT TO REMOVE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. DURING THE EVALUATION OF THE COMPLAINT SAMPLE, THE CAP CAME OFF WHEN TWISTED AND PULLED. CONCLUSION: NO DEVICE FAILURE DETECTED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TROCAR CAP CAN HARDLY BE REMOVED AND SOMETIMES THE STAFF NEEDS TO USE A BISTOVRY TO REMOVE THE TROCAR CAP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC NA 50841ISP

    Patients

    Seq Age Sex Outcome Treatment
    1