BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSA BOND

    MDR report key: 1695080 · Received May 17, 2010

    Report

    Report Number
    1020279-2010-00132
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 14, 2010
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MFG SITE
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED TO REPAIR A RIGHT FEMORAL NECK FRACTURE. AFTER INJECTING BONE CEMENT, THE PT EXPERIENCED AN ALLERGIC REACTION RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA BOND BONE CEMENT / LOD LOD SMITH & NEPHEW, INC., BROOKS MFG SITE 09DC01350

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death