BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 3893958 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08187
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS IMPLANTED AND SUTURED IN PLACE DEEP WITHIN THE PATIENT. ON (B)(6) 2014, THE NURSE PRACTITIONER ATTEMPTED TO PULL THE DRAIN. THE DRAIN BROKE DURING REMOVAL. IT WAS NOT ESTABLISHED WHETHER A PORTION OF THE DRAIN WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT THE REASON FOR THIS MAY BE THAT THE DISTAL END OF THE DRAIN IS OFTEN TRIMMED BEFORE INSERTING THEREFORE THERE IS NO WAY TO KNOW HOW MUCH DRAIN BEYOND THE BLACK DOT WAS IMPLANTED. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371263 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention