BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE LUBRICATING JELLY

    MDR report key: 17532219 · Received August 12, 2023

    Report

    Report Number
    MW5139127
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    May 25, 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 CALLED FOR THEIR DAUGHTER WHO USED STERILE LUBRICATING JELLY IN A KIT FOR A VENTILATOR. THE DAUGHTER HAS MULTIPLE INFECTIONS WHICH IS NOT A NORMAL OCCURRENCE. THE LOT NUMBERS PROVIDED DO NOT MATCH H AND P INDUSTRIES, INC. LOT NUMBERS OR PRODUCT NUMBERS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN PRODUCT INFORMATION TO VERIFY THE ADVERSE EVENT UNSUCCESSFULLY. 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
    1085721 STERILE LUBRICATING JELLY LUBRICANT, PATIENT KMJ H AND P INDUSTRIES, INC. 796C, 960C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown