BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAL WOUND CLEANSER 16OZ 01

    MDR report key: 19250259 · Received May 6, 2024

    Report

    Report Number
    8043484-2024-00042
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 9, 2024
    Report Date
    August 12, 2024
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NUP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE, AN ASSESSMENT WAS NOT PERFORMED. BATCH RECORDS TASK WAS UNABLE TO BE PERFORMED, AS NO LOT NUMBER WAS PROVIDED. A REVIEW CONCLUDED THAT THERE ARE NO PRIOR ESCALATED ACTIONS RELATED TO THIS PART NUMBER AND FAILURE MODE. AFTER A COMPLAINT HISTORY REVIEW PERFORMED BETWEEN 9TH APRIL 2023 TO 9TH APR2024 IT WAS REVEALED 6 SIMILAR EVENTS FOR THE LISTED PRODUCT FOR THE TIMEFRAME. IT WAS REPORTED THAT, ¿WHEN THREE ORDERS OF DERMAL WOUND CLEANSER 16OZ 01 WERE RECEIVED THEY WERE NOTICED TO BE LEAKING IN THE BOX. IT SEEMED THAT QUITE A FEW OF THE BOTTLE TOPS WEREN¿T SCREWED ON TIGHT, AND IT LOOKED LIKE THEY WEREN¿T TIGHT ENOUGH BEFORE PACKAGING CAUSING THEM TO LEAK. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NO PATIENT INVOLVED". AS DERMAL WOUND CLEANSER IS AN OTC DRUG (OVER THE COUNTER) IN THE US, A RISK MANAGEMENT FILE IS NOT MAINTAINED. CONSEQUENTLY, DERMAL WOUND CLEANSER COMPLAINTS ANALYZED IN THE LAST COMPLAINT DATA ANALYSIS REPORT (CDAR) HAVE BEEN REVIEWED TO ASCERTAIN FREQUENCY. A REVIEW OF COMPLAINTS BETWEEN 1ST JANUARY 2020 TO 3RD FEBRUARY 2024 IDENTIFIED 18 COMPLAINTS DETAILING LEAKAGE OF THE DEVICE. WITH A PROBABILITY/RISK RATING OF ¿ANH ¿ IMPROBABLE/LOW¿ (NH = NO HARM) THIS IS THE LOWEST POSSIBLE RATING ON THE RISK RATING MATRIX, AND THEREFORE CONSIDERED ACCEPTABLE. A POTENTIAL PROBABLE CAUSE FACTOR THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE THAT THE CAP IS NOT FULLY SECURE OR THAT IT HAD BECOME LOOSE. NO MANUFACTURING, PACKAGING, LABELLING, DESIGN, CONCERNS NOR ADVERSE TREND HAVE BEEN OBSERVED; THEREFORE, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN THREE ORDERS OF DERMAL WOUND CLEANSER 16OZ 01 WERE RECEIVED THEY WERE NOTICED TO BE LEAKING IN THE BOX. IT SEEMED THAT QUITE A FEW OF THE BOTTLE TOPS WEREN¿T SCREWED ON TIGHT, AND IT LOOKED LIKE THEY WEREN¿T TIGHT ENOUGH BEFORE PACKAGING CAUSING THEM TO LEAK. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763412 DERMAL WOUND CLEANSER 16OZ 01 CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER NUP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown