BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 1964766 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01733
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN UNK PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS PLACED. THE DRAINAGE WAS WEAK BECAUSE THE DRAIN HAD A CRACK. THE SURGEON CUT THE DRAIN NEAR THE CRACKED AREA AND RE-CONNECTED THE RESERVOIR, THEN THE DRAIN WORKED NORMALLY. 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 50089ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK