BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23-3659-0 PURELL HAND SANITIZER GEL 12FL. OZ. 12/CS

    MDR report key: 23862893 · Received December 22, 2025

    Report

    Report Number
    MW5180873
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - READYCARE HARTLAND
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED TO CUSTOMER SERVICE TO REPORT THE SILK TAPE MAKES HER BREAKOUT WITH RASHES AND SHE DOES NOT NEED ANYTHING REPLACED, THE PATIENT INVOLVEMENT WAS UNKNOWN; HOWEVER, THERE WAS NO HARM OR ADVERSE EVENT REPORTED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874779 23-3659-0 PURELL HAND SANITIZER GEL 12FL. OZ. 12/CS DISINFECTANT, MEDICAL DEVICES LRJ MEDLINE INDUSTRIES, LP - READYCARE HARTLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown