BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2010685 · Received February 25, 2011

    Report

    Report Number
    2210968-2011-00208
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    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)(6): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 50831ISP, MFG DATE: 02/19/2010, EXP DATE: 02/28/2015. BATCH 50899ISP, MFG DATE: 03/19/2010, EXP DATE: 03/31/2015. BATCH 51559ISP, MFG DATE: 09/01/2010, EXP DATE: 03/31/2015. IN ADDITION, A REVIEW OF THE BATCH MFG 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 PT UNDERWENT LAMINECTOMY PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED IN THE SPINE AND WAS ANCHORED BY SUTURING. THE NEXT DAY, THE DRAIN BROKE WHEN IT WAS REMOVED FROM THE PT'S BODY. A RE-OPERATION WAS PERFORMED ON (B)(6) 2011 TO REMOVE THE RETAINED FRAGMENT. THE PT'S CONDITION IS STABLE AND HE WAS DISCHARGED ON (B)(6) 2011. THE SURGEON OPINES THAT THE DRAIN MAY HAVE COME IN CONTACT WITH SURGICAL INSTRUMENTS OR SUTURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention