BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 3030334 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03253
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1227730 MFG DATE: 04/01/2012, EXP DATE: 04/30/2017. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL HEAD REPLACEMENT ON (B)(6) 2013. DURING THE SURGERY, A DRAIN WAS PLACED UNDER THE FASCIA OF THE HIP JOINT. ON (B)(6) 2013, WHILE ATTEMPTING TO REMOVE THE DRAIN, THE DRAIN BROKE. ON (B)(6) /2013, THE PATIENT UNDERWENT A RE-OPERATION TO REMOVE THE DRAIN. THE PATIENT IS CURRENTLY HOSPITALIZED BUT IN STABLE CONDITION. THERE ARE NO PLANS FOR ANY ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133762 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention