BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000CC SUCTION LINER WITH ORTHO PORT

    MDR report key: 61622 · Received January 10, 1997

    Report

    Report Number
    1623486-1996-00127
    Event Type
    Malfunction
    Date Received
    January 10, 1997
    Date of Event
    December 11, 1996
    Report Date
    December 11, 1996
    Manufacturer
    ALLEGIANCE- SURGICAL GRP
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LIPOSUCTION PROCEDURE, THE CANISTER IMPLODED ALLOWING THE CONTENTS OF THE CANISTER TO SPILL OUT. IN ADDITION THE CANISTER LID FRACTURED INTO SEVERAL PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3000CC SUCTION LINER WITH ORTHO PORT SUCTION LINER KDQ ALLEGIANCE- SURGICAL GRP 65651-530 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other BYRON HI-VAC TUBING, 8"