BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1051705 · Received May 21, 2008

    Report

    Report Number
    2210968-2008-00362
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE SURGEON REPORTS THAT SUTURE WAS LOOPED TIGHTLY AROUND THE DEVICE. THIS MAY HAVE CAUSED THE DRAINAGE TO BE IMPAIRED. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THE PROD UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PROD IS REC'D, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT THE DEVICE WAS PLACED FOLLOWING A LAMINECTOMY. SUTURE WAS TIGHTLY LOOPED AROUND THE DRAIN TO SECURE ITS PLACEMENT. THE PT DEVELOPED A HEMATOMA WITHIN ONE HR OF THE PROCEDURE. THERE WAS LOW DRAINAGE VOLUME NOTED. THE PT WAS RETURNED TO SURGERY, THE DEVICE EXPLANTED AND A NEW DRAIN PLACED. THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA 46132ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SUTURE - NOT SPECIFIED