BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1822860 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-00979
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCTION UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH 50461ISP MFG DATE: 11/17/2009, EXP DATE: 11/30/2014. 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 A SUPPURATIVE MYELITIS SPINAL FUSION PROCEDURE OF THE CERVICAL SPINE ON (B)(6) 2010 AND A DRAIN AND RESERVOIR WERE PLACED. THE DEVICES WORKED PROPERLY UPON FIRST ACTIVATION. LATER THAT DAY, THE DRAIN BECAME CLOGGED AND BLOOD LEAKED FROM THE DRAIN SITE. THE PATIENT DEVELOPED A HEMATOMA, 4CMX1.5CMX1CM. A RE-OPERATION WAS PERFORMED ON THE SAME DAY TO PLACE A DIFFERENT DRAIN AND TO REMOVE THE HEMATOMA. THE SURGEON OPINES THAT THE DRAIN BECAME CLOGGED BECAUSE THE HEMATOMA GOT STUCK IN THE DRAIN.

    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 52 YR Required Intervention