BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 3731234 · Received April 7, 2014

    Report

    Report Number
    2210968-2014-04383
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 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
    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 # J1349596 MFG. DATE 2013-07, EXP. DATE 2018-07. BATCH # J1349590 MFG. DATE 2013-05, EXP. DATE 2018-05. BATCH # J1364805 MFG. DATE 2013-05, EXP. DATE 2018-05. BATCH # J1349597 MFG. DATE 2013-07, EXP. DATE 2018-07. BATCH # J1349598 MFG. DATE 2013-07, EXP. DATE 2018-07. BATCH # J1349599 MFG. DATE 2013-07, EXP. DATE 2018-07. BATCH # J1349601 MFG. DATE 2013-07, EXP. DATE 2018-07. 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 AN OOPHOROCYSTECTOMY ON (B)(6) 2014. A DRAIN WAS PLACED IN DOUGLAS' POUCH THEN ACTIVATED. SEVERAL HOURS AFTER SURGERY THE DRAIN WAS REMOVED FROM THE PATIENT, BUT OMENTUM TANGLED WITH THE DRAIN AND CAME OUT TOGETHER FROM THE BODY. THE PATIENT REQUIRED A RE-OPERATION. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS IN STABLE CONDITION. THE OPERATING SURGEON OPINES THAT THE CAUSE MAY BE THAT THE PHYSICIAN REMOVED THE DRAIN EVEN THOUGH NEGATIVE PRESSURE WAS STILL BEING APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208984 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention