BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR. SHEFFIELD MUBRIGEL PERSONAL LUBRICANT JELLY

    MDR report key: 4173294 · Received September 26, 2014

    Report

    Report Number
    1210513-2014-00001
    Event Type
    Injury
    Date Received
    September 26, 2014
    Manufacturer
    SHEFFIELD PHARMACEUTICALS
    Product Code
    NUC
    PMA / PMN Number
    K001077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT (REPORTER) STATED THAT AFTER USING DR. SHEFFIELD LUBRIGEL PERSONAL LUBRICANT JELLY HE EXPERIENCED REDNESS AND SPLITTING OF THE FORESKIN ON HIS PENIS. HE ALSO INDICATED THAT HIS PARTNER EXPERIENCED SWELLING AND REDNESS ON HER LIPS. A POSTAGE PAID ENVELOPE WAS SENT REQUESTING THE RETURN OF THE SUSPECT PRODUCT. HOWEVER, THE REQUESTED PRODUCT OR LOT CODE WAS NOT MADE AVAILABLE BY THE PT. AS PER THE PT, MEDICAL ATTENTION WAS NOT SORT TO TREAT THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600689 DR. SHEFFIELD MUBRIGEL PERSONAL LUBRICANT JELLY NONE NUC SHEFFIELD PHARMACEUTICALS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other