BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 3909780 · Received July 2, 2014

    Report

    Report Number
    2210968-2014-08618
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 J1239036, BATCH J1239043.

    Additional Manufacturer Narrative · 1

    (B)(4): THE BROKEN SURFACE OF THE DRAIN PIECE IS INDENTED AND HAS SIGNS OF SMALL CUTS. THE DRAIN COULD BE SLIGHTLY DAMAGED DURING THE MANIPULATION, AND BREAK AT THE DAMAGED PLACE.ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH J1239036 MNF. DATE 08/01/2012, EXP. DATE 08/31/2017.BATCH J1239043 MNF. DATE 08/01/2012, EXP. DATE 08/31/2017.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 SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST OPERATIVELY, THE DRAIN WAS REMOVED. WHEN THE WOUND WAS BEING CLEANED, IT WAS NOTED THAT A SMALL PIECE OF A FOREIGN BODY COULD BE FELT BY TOUCH SUPERFICIALLY ON THE WOUND. THE FOREIGN BODY WAS FOUND TO BE APPROXIMATELY 1 CM OF THE DRAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387778 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other