BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMINUTIVE PORP

    MDR report key: 118146 · Received September 3, 1997

    Report

    Report Number
    1037007-1997-00004
    Event Type
    Injury
    Date Received
    September 3, 1997
    Date of Event
    July 25, 1997
    Report Date
    September 3, 1997
    Manufacturer
    SMITH & NEPHEW INC./ENT DIVISION
    Product Code
    ETB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER A TELEPHONE CALL FROM THE HOSPITAL'S MATERIAL MANAGEMENT DEPT, THE PRODUCT WAS EXPLANTED ON 7/25/97 AND THE PLATFORM HAD SEPARATED FROM THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMINUTIVE PORP Implant PORP ETB SMITH & NEPHEW INC./ENT DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention