BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2954214 · Received November 22, 2006

    Report

    Report Number
    2210968-2006-00785
    Event Type
    Injury
    Date Received
    November 22, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 23, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K014129
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: PT WAS DETERMINED TO HAVE AN ALLERGIC REACTION TO SOME COMPONENT OF THE DEVICE. NO DEVICE FAILURE NOTED.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE BROKE DURING REMOVAL ONE DAY POST SURGERY. THE PT WAS RETURNED TO SURGERY THE SAME DAY FOR EXCISION OF THE RETAINED FRAGMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention