BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 1903401 · Received November 12, 2010

    Report

    Report Number
    2210968-2010-01517
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MCN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADD'L INFO: THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE DEVICES: SURGICEL ABSORBABLE HEMOSTAT, INTERCEED (TC7) ABSORBABLE ADHESION BARRIER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2010. THREE WEEKS LATER, THE PT RETURNED WITH COMPLAINT OF PAIN. ON (B)(6) 2010, THE SURGEON FOUND AND REMOVED A PIECE OF HARDENED MATERIAL FROM UNDER THE PT'S THYROID NECK MUSCLE. THE SIZE OF THE HARDENED MATERIAL WAS 20CM. CURRENTLY, THE PT IS STABLE AND DISCHARGED FROM THE HOSPITAL. THE NURSE HAS INDICATED THAT THE HARDENED MATERIAL MAY NOT BE ABSORBABLE HEMOSTAT OR ABSORBABLE ADHESION BARRIER AND IS NOW UNWILLING TO PROVIDE ADD'L DETAILS OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT UNKNOWN MCN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention