BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAKIN'S SOLUTION 473ML

    MDR report key: 18474943 · Received January 8, 2024

    Report

    Report Number
    MW5149944
    Event Type
    Other
    Date Received
    January 8, 2024
    Manufacturer
    CENTURY PHARMACEUTICALS, INC.
    Product Code
    FRO
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DAKIN'S SOLUTION QUARTER STRENGTH (BY CENTURY PHARMACEUTICALS) IS IN A BOTTLE THAT LOOKS LIKE BULK BOTTLES USED FOR ORAL SOLUTIONS. HOWEVER, IT IS FOR TOPICAL USE ONLY BUT THERE ARE NO WARNINGS. HYSEPT (BY PATRIN PHARMA) HAS A MUCH DIFFERENT SHAPE AND DIFFERENT SPOUT/TOP AND ALSO STATES "TOPICAL USE ONLY" ON THE LABEL. (B)(4) IS A FEDERALLY CERTIFIED PATIENT SAFETY ORGANIZATION AND AN FDA MEDWATCH PARTNER. (B)(4). REFERENCE REPORTS: MW5149943, MW5149945.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003089 DAKIN'S SOLUTION 473ML DRESSING, WOUND, DRUG FRO CENTURY PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown