BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 613707 · Received June 15, 2005

    Report

    Report Number
    2210968-2005-00335
    Event Type
    Injury
    Date Received
    June 15, 2005
    Date of Event
    May 1, 2005
    Report Date
    May 17, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    LMG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED HEMOSTAT APPLIED ON PARTIAL AMPUTATION TO STOP BLEEDING AND FACILITATE NEW TISSUE GROWTH IN 2005. THE ONSET OF THE BLISTER WAS LATER IN 2005. PT WAS STARTED ON PREDNISONE WITHOUT RESPONSE. PT SAW SPECIALIST IN 5/2005 WHO OPINED THAT REACTION IS AN ALLERGIC REACTION TO THE HEMOSTAT. THE PT'S CONDITION IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention