BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF CLENS AF SPRAY

    MDR report key: 5113182 · Received September 30, 2015

    Report

    Report Number
    1628114-2015-30106
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Report Date
    February 27, 2014
    Manufacturer
    DPT LABORATORIES, LTD.
    Product Code
    KMF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE ARE THINGS IN THE BOTTOM OF THE BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644286 SAF CLENS AF SPRAY BANDAGE, LIQUID KMF DPT LABORATORIES, LTD. 159712 D7K124

    Patients

    Seq Age Sex Outcome Treatment
    1