BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S.SCORT DUET

    MDR report key: 210714 · Received February 12, 1999

    Report

    Report Number
    2022724-1999-00001
    Event Type
    Malfunction
    Date Received
    February 12, 1999
    Date of Event
    January 6, 1999
    Report Date
    February 12, 1999
    Manufacturer
    SSCOR, INC.
    Product Code
    BTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 25, 1999 SSCOR REC'D A S-SCORT DUET ASPIRATOR MODEL # 2014 FOR REPAIR. A SSCOR TECHNICIAN EVALUATED THE UNIT. THE DEVICE WAS FOUND TO HAVE A NON-FUNCTIONAL MODEL 007BDC19 PUMP. THE PUMP WAS FOUND TO HAVE A BROKEN ECCENTRIC ASSEMBLY. SUBSEQUENT TO THE EVAL, SSCOR CONTACTED DR, THE OWNER OF THE ASPIRATOR. DR EXPLAINED THE ASPIRATOR IS USED IN POST-OPERATIONAL PROCEDURES TO DRAIN FACE LIFT PTS. NO ONE WAS INJURED DUE TO THE PUMP FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.SCORT DUET BATTERY OPERATED PORTABLE SUCTION PUMP BTA SSCOR, INC. S.SCORT DUET NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other