BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC TENDON SPACER H.P. (SWANSON-HUNTER DESIGN)

    MDR report key: 54203 · Received December 4, 1996

    Report

    Report Number
    1816403-1996-00350
    Event Type
    Injury
    Date Received
    December 4, 1996
    Report Date
    November 1, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    HXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGES PT'S INDEX MCP JOINT SPACER DEVICE WAS "BROKEN"; THEREFORE, HAD IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC TENDON SPACER H.P. (SWANSON-HUNTER DESIGN) Implant SILASTIC TENDON SPACER H.P. (SWANSON-HUNTER DESIGN) HXA DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention