BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE LUBRICATING JELLY

    MDR report key: 17528549 · Received August 12, 2023

    Report

    Report Number
    MW5135479
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    December 1, 2010
    Report Date
    June 14, 2011
    Manufacturer
    H AND P INDUSTRIES, INC.
    Product Code
    KMJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AN ADVERSE EVENT WAS CALLED IN FROM THE CUSTOMER FOR AN END USER. THE CUSTOMER HAD A PROCEDURE ON (B)(6) 2010 IN WHICH LUBE JELLY WAS USED AND SHE HAD A POSSIBLE REACTION. THE REPORTING CUSTOMER SAID THEY DO NOT HAVE A RECORD OF THE LOT CODE AND WAS NOT SURE IF THE REACTION WAS DUE TO THE LUBE JELLY OR OTHER CHANGES IN MEDICATION. AT THIS TIME, IT CANNOT BE CONFIRMED THAT THE PRODUCT IS STERILE LUBRICATING JELLY MANUFACTURED BY H AND P INDUSTRIES, INC. AND DISTRIBUTED BY THE (B)(4). COMPLAINT INVESTIGATION CALL ID: (B)(4). 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
    2218546 STERILE LUBRICATING JELLY LUBRICANT, PATIENT KMJ H AND P INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown