BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2087449 · Received May 12, 2011

    Report

    Report Number
    2210968-2011-00634
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    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

    DATE SENT TO THE FDA: (B)(4) 2011.THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH 51559ISP MFG DATE: 09/01/2010, EXP DATE: 08/31/2015BATCH J102218 MFG DATE: 05/01/2010, EXP DATE: 05/31/2015BATCH J103190 MFG DATE: 06/01/2010, EXP DATE: 06/30/2015BATCH J103191 MFG DATE: 06/01/2010, EXP DATE: 06/30/2015IN 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 TOTAL HIP ARTHROPLASTY IN (B)(6) 2011 AND A DRAIN WAS PLACED AT HIP JOINT. APPROXIMATELY TWO WEEKS AFTER THE INITIAL SURGERY, THE PATIENT HAD A XRAY OF THE ARTIFICIAL FEMORAL HEAD AND A MATTER LIKE CORD WAS VISIBLE. THE MATTER COULD BE FOUND ON THE PICTURE WHEN IT WAS TAKEN FROM OBLIQUE ANGLE, BUT IT COULD NOT BE SEEN ON THE FRONTAL VIEW. THE SURGEON OPINES IT WAS THE DRAIN AND THAT WHEN THE DRAIN WAS REMOVED, IT MAY HAVE BROKE AND REMAINED IN THE PATIENT'S BODY. NO RESISTANCE WAS MET AT THE TIME OF THE DRAIN REMOVAL. THE SURGEON DOES NOT PLAN TO REOPERATE TO REMOVE THE MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1