BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 6048371 · Received October 21, 2016

    Report

    Report Number
    2210968-2016-14477
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    October 4, 2016
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    THE BROKEN PIECE HAS QUIRE INDENTED SURFACE, SUITABLE FOR BREAKAGE FOLLOWING SOME MECHANICAL DAMAGE. THE DRAIN COULD BREAK FOLLOWING NICK OR CUT DURING ITS USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND DRAIN WAS IMPLANTED. THE DRAIN BROKE ON REMOVAL WITH A PORTION OF THE DRAIN REMAINING IN THE PATIENT. AN UNKNOWN INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698740 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention