BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1973883 · Received January 20, 2011

    Report

    Report Number
    2210968-2011-00054
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    November 12, 2010
    Report Date
    December 20, 2010
    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 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 50716ISP, MFG DATE: 01/18/2010, EXP DATE: 01/31/2015. BATCH 50717ISP, MFG DATE: 01/28/2010, EXP DATE: 01/31/2015. BATCH 50718ISP, MFG DATE: 02/02/2010, EXP DATE: 01/31/2015. BATCH 50719ISP, MFG DATE: 01/21/2010, EXP DATE: 01/31/2015. BATCH 50831ISP, MFG DATE: 02/19/2010, EXP DATE: 02/28/2015. BATCH 50832ISP, MFG DATE: 02/26/2010, EXP DATE: 02/28/2015. 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 AN ORTHOPEDIC PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS PLACED AND WORKED NORMALLY. ON (B)(6) 2010, THE SURGEON REMOVED THE DRAIN AND IT BROKE. A PIECE OF THE DRAIN REMAINED IN THE PT'S BODY. THE SURGEON FELT NO RESISTANCE WHEN HE REMOVED IT. ON THE SAME DAY, THE SURGEON RE-OPENED PART OF SURGICAL INCISION AND REMOVED THE RETAINED DRAIN. THE SURGEON OPINES THAT THE DRAIN MAY HAVE COME IN CONTACT WITH A NEEDLE OR SCISSORS WHILE SUTURING THE FASCIA. THE PT IS IN STABLE CONDITION.

    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 40 YR Required Intervention