BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUNTSVILLE LAP CHOLE

    MDR report key: 14186195 · Received April 22, 2022

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    Report

    Report Number
    14186195
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 20, 2022
    Manufacturer
    PACKROOM LLC
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PACK ROOM LLC SENT A LAP CHOLE PACK THAT HAD 2 PACKS OF RAYTEXS IN IT. IT IS SUPPOSED TO ONLY COME WITH ONE PACK OF RAYTEX. MANUFACTURER RESPONSE FOR LAPAROSCOPIC CHOLECYSTECTOMY, (HUNTSVILLE LAP CHOLE) (PER SITE REPORTER) NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771603 HUNTSVILLE LAP CHOLE LAPAROSCOPY KIT FDE PACKROOM LLC HH270 31400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown