BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 18639157 · Received February 5, 2024

    Report

    Report Number
    2243072-2024-05002
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Report Date
    May 2, 2024
    Manufacturer
    HDQ PARSIPPANY
    Product Code
    MMK
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : PRODUCT NOT AVAILABLE

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED LID IS MISSING FROM SHARPS CONTAINER PRIOR TO USE. DISCARDED BOX. PRODUCT INFORMATION IS NOT AVAILABLE STATED, SHE PURCHASED A 1.4QT. SHARPS CONTAINER. DATE OF EVENT: UNKNOWN SAMPLE: NO CL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249063 UNKNOWN CONTAINER, SHARPS MMK HDQ PARSIPPANY UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown