BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 1962936 · Received December 22, 2010

    Report

    Report Number
    2210968-2010-01730
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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 INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2010. PRIOR TO PLACING THE DRAIN, THE PROTECTIVE SHEATH WHICH IS PLACED OVER THE TROCAR WAS ONLY ABLE TO BE REMOVED BY "BRUTE FORCE". THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA 50343ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK