BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2446720 · Received February 10, 2012

    Report

    Report Number
    2210968-2012-00340
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 20, 2012
    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

    DATE SENT TO THE FDA: 03/09/2012. THE SURGEON OPINES THAT HE MAY HAVE ACCIDENTALLY SUTURED THE DRAIN WHEN HE SUTURED THE FASCIA AND SUBCUTANEOUS LAYER AT THE SURGICAL INCISION SITE. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1112491, MFG DATE: 06/01/2011, EXP DATE: 07/31/2016; BATCH J1102135, MFG DATE: 02/01/2011, EXP DATE: 02/29/2016; BATCH J1021513, MFG DATE: 12/01/2010, EXP DATE: 12/31/2015; BATCH J1010651, MFG DATE: 08/01/2010, EXP DATE: 08/31/2015; BATCH J103193, MFG DATE: 06/01/2010, EXP DATE: 06/30/2015; BATCH 50900ISP, MFG DATE: 03/17/2010, EXP DATE: 03/31/2015; BATCH 51513ISP, MFG DATE: 08/23/2010, EXP DATE: 06/30/2015. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH J1112491,BATCH J1102135,BATCH J1021513,BATCH J1010651,BATCH J103193,BATCH 50900ISP,BATCH 51513ISP.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO PIECES OF DRAIN WERE RETURNED FOR EVALUATION. THERE ARE MULTIPLE CUTS ON BOTH PIECES IN THE AREA OF THE BREAKAGE. THE DRAIN COULD HAVE BEEN SUTURED BY THE SURGEON AND THEN WAS DAMAGED ON ATTEMPTS TO REMOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MICRO ENDOSCOPIC DISCECTOMY ON (B)(6) 2012 AND A DRAIN WAS PLACED AT THE 4TH TO 5TH LUMBAR SPINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2012, RESISTANCE WAS MET WHEN TRYING TO REMOVE THE DRAIN FROM THE PATIENT. THE SURGEON TRIED TO REMOVE IT LITTLE BY LITTLE, BUT WHEN HE RELAXED HIS GRIP ON THE DRAIN, IT WENT BACK INTO THE PATIENT'S BODY. THEN THE SURGEON CHANGED THE PATIENT'S BODY POSTURE, COILING, BUT THE DRAIN COULD NOT BE REMOVED. FINALLY, THE DRAIN BROKE AND REMAINED IN THE PATIENT'S BODY. THE PATIENT UNDERWENT REOPERATION THAT SAME DAY, WHICH WAS COMPLETED SUCCESSFULLY AND THE BROKEN DRAIN FRAGMENT WAS RETRIEVED AND REMOVED FROM THE PATIENT'S BODY. CURRENTLY, THE PATIENT IS HOSPITALIZED AND IN STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention