BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2882819 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08370
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 3, 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). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT 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 NUMBERS: BATCH J1227606, MFG DATE: 02/01/2012, EXP DATE: 02/28/2017. BATCH J1227623, MFG DATE: 03/01/2012, EXP DATE: 03/31/2017. BATCH J1227608, MFG DATE: 02/01/2012, EXP DATE: 02/28/2017. 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 NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION ON (B)(6) 2012 AND A DRAIN WAS INSERTED. ON (B)(6) 2012, WHEN REMOVING THE DRAIN, THE DRAIN BROKE. THE PATIENT WAS RE-OPERATED ON THE SAME DAY TO REMOVE THE FRAGMENT OF THE DRAIN. THE RE-OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS HOSPITALIZED TWO DAYS LONGER. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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