BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 4896066 · Received July 7, 2015

    Report

    Report Number
    2210968-2015-07963
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 15, 2015
    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
    OTHER

    Narratives

    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.ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH #: J1423890,BATCH #: J1427564,BATCH #: J1429163,BATCH #: J1429180,BATCH #: J1429963.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN OPINES THAT THE ARTERIAL HEMORRHAGE CAUSED BY THE SHARP EDGE OF THE TROCAR. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH # J1423890; MFG DATE 08/2014; EXPIRATION DATE 08/2019. BATCH # J1427564; MFG DATE 09/2014; EXPIRATION DATE 09/2019. BATCH # J1429163; MFG DATE 09/2014; EXPIRATION DATE 09/2019. BATCH # J1429180; MFG DATE 09/2014; EXPIRATION DATE 09/2019. BATCH # J1429963; MFG DATE 09/2014; EXPIRATION DATE 09/2019. 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 THE PATIENT UNDERWENT AN UNKNOWN ABDOMINAL SURGERY ON UNKNOWN DATE AND DRAIN WAS INSERTED. AFTER ABOUT ONE HOUR, ARTERIAL HEMORRHAGE WAS CONFIRMED AROUND THE INSERTED PART. DUE TO THIS, ADDITIONAL OPERATION WITH SUTURING WAS PERFORMED AT THE TREATMENT ROOM IN A WARD. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438876 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK J1427564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention