BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1822864 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-00982
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS PLACED THE DRAIN WAS SUTURED CAREFULLY TO KEEP THE BLACK MARK OF THE DRAIN ON THE SURFACE OF THE PATIENT'S BODY. ON (B)(6) 2010, THE SURGEON TRIED TO REMOVE THE DRAIN FROM THE PATIENT'S BODY. THE SURGEON FELT SOME RESISTANCE, SO HE CAREFULLY REMOVED IT WITH FORCEPS, BUT THE DRAIN BROKE AND ABOUT 15CM OF THE DRAIN REMAINED IN THE PATIENT'S BODY. THEN, THE SURGEON RE-OPENED THE PATIENT WITH A SMALL INCISION TO REMOVE THE RETAINED DRAIN. THE PATIENT IS STABLE AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THE SURGEON OPINES THAT THE CAUSE WAS THE DRAIN MAY HAVE COME IN CONTACT WITH THE NEEDLE WHILE CLOSING THE WOUND SITE OR THE SURGICAL SITE MAY HAVE BEEN TOO TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA 50517ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention