BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2832329 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07307
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH J1227618.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. IT WAS BROKEN 3 CM UNDER ITS BLACK DOT. THE BROKEN AREA IS VERY INDENTED AND UNEVEN. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH J1227618, MFG DATE: 03/01/2012, EXP DATE: 03/31/2017. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2012 AND A DRAIN WAS USED. AFTER THE SURGERY THE PATIENT PULLED THE DRAIN OUT. IT WAS NOTED THAT THE DRAIN WAS BROKEN AND A REMAINED IN THE PATIENT. ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY TO REMOVE THE DRAIN. THE PATIENT'S CONDITION IS NOW STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention