BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 4197189 · Received October 23, 2014

    Report

    Report Number
    2210968-2014-14890
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HEMOSTASIS WAS ACHIEVED AND VERIFIED IN THE ENTIRE SURGICAL FIELD BEFORE THE CONCLUSION OF THE PROCEDURE. THE DRAIN DID NOT FUNCTION AS INTENDED AND THE PATIENT EXPERIENCED INADEQUATE SUCTION. THE CURRENT PATIENT STATUS IS STABLE.

    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 INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1394988, BATCH J1396723, BATCH J1498240, BATCH J1400379, BATCH J1401105, BATCH J1401866. 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. BATCH # J1394988, MFG DATE: 12/2013, EXP DATE: 12/2018. BATCH # J1396723, MFG DATE: 12/2013, EXP DATE: 12/2018. BATCH # J1498240, MFG DATE: 01/2014, EXP DATE: 01/2019. BATCH # J1400379, MFG DATE: 02/2014, EXP DATE: 02/2019. BATCH # J1401105, MFG DATE: 02/2014, EXP DATE: 02/2019. BATCH # J1401866, MFG DATE: 02/2014, EXP DATE: 02/2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PROCEDURE TO REPAIR A HEMATOMA FOLLOWING POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE AND A DRAIN WAS PLACED. THE PATIENT WAS ADMINISTERED ANTICOAGULANT. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED HEMATOMA AND RE-OPERATION WAS PERFORMED FOR TREATMENT OF HEMATOMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676171 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention