BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2828775 · Received November 12, 2012

    Report

    Report Number
    2210968-2012-07188
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 15, 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

    THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH # J1112490; MFG DATE 2011-06; EXPIRATION DATE 2016-06. BATCH # J1226554; MFG DATE 2012-01; EXPIRATION DATE 2017-01. BATCH # J1226555; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227606; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227607; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227609; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227615; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227616; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227619; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227620; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227621; MFG DATE 2012-02; EXPIRATION DATE 2017-02. BATCH # J1227622; MFG DATE 2012-02; EXPIRATION DATE 2017-02. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-01789. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROTOMY ON (B)(6) 2012 AND A DRAIN WAS USED. THE DRAIN WAS INSERTED FROM LEFT ABDOMEN, WITH A TRANSVERSE INCISION SITE OF 20 CM, AND THE DRAIN TIP WAS PLACED AT LEFT ABDOMEN. THE DRAIN WAS PLACED UNDER THE SKIN AND CONNECTED TO A RESERVOIR. SEVEN HOURS POSTOPERATIVELY, FRAGMIN WAS ADMINISTERED. ON (B)(6) 2012, THIRTY HOURS POST OP, THE PATIENT CHANGED HER POSITION AND COMPLAINED OF ABDOMINAL PAIN. HER ABDOMEN SWELLED AND A SUBCUTANEOUS HEMATOMA WAS NOTED. SHE HAD HEAVY BLEEDING WHICH THE SURGEON OPINED MAY HAVE BEEN AN ARTERIAL BLEED. ON (B)(6) 2012, THE PATIENT HAD A SUBCUTANEOUS HEMATOMA ABOUT 20 CM IN SIZE, AND HER HEMOGLOBIN LEVEL RAPIDLY FELL FROM 12 TO 7. THE PATIENT UNDERWENT A CT SCAN WHICH SHOWED THE BLEEDING WAS FROM THE AREA AROUND THE TIP OF THE DRAIN. THERE WAS LITTLE FLUID FROM THE DRAIN. THE FLUID AND BLOOD LEAKED OUT OF THE INCISION SITE WHICH HAD BEEN SUTURED WITH A DERMOSTITCH TECHNIQUE. BEFORE THIS PROCEDURE, ADMINISTRATION OF FRAGMIN HAD ALREADY FINISHED. AND THEN, PROTAMIN ADMINISTRATION WAS STARTED FOR NEUTRALIZATION OF THE FRAGMIN. THE PATIENT UNDERWENT REOPERATION UNDER GENERAL ANESTHESIA. BLOOD TRANSFUSION WAS STARTED, AND THE WOUND SITE WAS OPENED. THE HEAVY BLEEDING WAS UNDER THE SKIN, BUT THE OBVIOUS BLEEDING POINT WAS NOT FOUND, SO THE PRESSURE POINT WAS SUTURED AND THE BLEEDING WAS STOPPED.

    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