BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1910232 · Received November 22, 2010

    Report

    Report Number
    2210968-2010-01542
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    June 15, 2009
    Report Date
    October 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2009 AND A DRAIN WAS PLACED. THE DRAIN WAS REMOVED WITHOUT RESISTANCE ON (B)(6) 2010. A CT SCAN WAS PERFORMED ON (B)(6) 2010, 14 MONTHS LATER, BECAUSE THE PT WAS EXPERIENCING HEMATURIA. A RETAINED PIECE OF THE DRAIN TUBING WAS FOUND ON THE CT SCAN LOCATED IN THE PT'S ABDOMEN. THE FRAGMENT WAS REMOVED UNDER GENERAL ANESTHESIA, CONDUCTED AS A DAY PROCEDURE. THE PT IS BACK TO WORK WITH NO OBVIOUS LONG TERM INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention