BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ- LUBRICATING JELLY

    MDR report key: 3731352 · Received March 26, 2014

    Report

    Report Number
    1022110-2014-00001
    Event Type
    Injury
    Date Received
    March 26, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CHESTER LABS, INC.
    Product Code
    KMJ
    PMA / PMN Number
    K041060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS SEEING AN ALLERGIST WHO WANTED MORE INFO ABOUT EZ LUBE JELLY AND THAT IS WHY THE PHYSICIAN'S OFFICE CONTACTED US. THEY REQUESTED LITERATURE, PACKAGE INFO, AND AN INGREDIENT STATEMENT. CHESTER PACKAGING'S CUSTOMER SERVICE DEPARTMENT FORWARDED A LIST OF INGREDIENTS. IN ADDITION, AN INGREDIENT STATEMENT WITH PACKAGE USED INSTRUCTIONS WAS ALSO SENT TO THE PHYSICIAN'S OFFICE. THE PATIENT'S ALLERGIST AND PHYSICIAN'S OFFICE HAVE NOT CONFIRMED THAT THE LUBE JELLY CAUSED OR CONTRIBUTED TO THE INCIDENT BUT CHESTER PACKAGING IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE REPORTED THAT ONE PATIENT EXPERIENCED AN ALLERGIC REACTION ON TWO SEPARATE OCCASIONS. THE INCIDENTS OCCURRED AT DIFFERENT LOCATIONS AND AN ATTEMPT WAS MADE TO IDENTIFY A POTENTIAL SOURCE OF THE ALLERGIC RESPONSE. A ROOT CAUSE WAS NOT CONFIRMED BUT USE OF THE LUBRICATING JELLY WAS COMMON TO BOTH INCIDENTS. THE FIRST INCIDENT OCCURRED IN THE OFFICE AND WAS MINOR. THE SECOND REACTION OCCURRED DURING A COLONOSCOPY AND THE PT DEVELOPED ITCHING, HIVES, SWELLING OF THE THROAT AND SHORTNESS OF BREATH. THE SYMPTOMS RESOLVED AND IT IS NOT KNOWN IF ANY MEDICAL INTERVENTION WAS INITIATED. THE PT HAS KNOWN ALLERGIES TO BEE STINGS AND VARIOUS MEDICATIONS INCLUDING BUT NOT LIMITED TO PENICILLIN AND POSSIBLY SULFA. NO LOT NUMBER WAS AVAILABLE FOR EITHER PRODUCT USED. THE PATIENT IS CURRENTLY BEING FOLLOWED BY ALLERGIST. THE PATIENT'S PHYSICIANS HAVE NOT CONFIRMED THE LUBE JELLY CAUSED OR CONTRIBUTED TO THE ALLERGIC REACTION BUT IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176494 EZ- LUBRICATING JELLY LUBRICATING JELLY KMJ CHESTER LABS, INC. 000304 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other