BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALOGYN

    MDR report key: 8523258 · Received April 17, 2019

    Report

    Report Number
    9610200-2019-00004
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 24, 2019
    Report Date
    April 17, 2019
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    NUC
    PMA / PMN Number
    K094039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THIS IS A SPONTANEOUS REPORT FROM A CONSUMER, RECEIVED THROUGH (B)(4). A PATIENT, AFTER THE USE OF THE PRODUCT HYALOGYN, EXPERIENCED ALLERGIC REACTION TO EXCIPIENT, VAGINAL BLEEDING AND URINARY TRACT INFECTION IN A CONTEXT OF MEDICATION ERROR. IN FACT, THE PATIENT WAS PRESCRIBED HYALOGYN, BUT SHE HAD A KNOWN ALLERGY TO PROPYLENE GLYCOL THAT IS AN INGREDIENT OF THE PRODUCT. THE CASE HAS BEEN DEEMED AS SERIOUS BY THE COMPANY DUE TO MEDICALLY IMPORTANT CONDITION. THE CASE HAS BEEN DEEMED AS SERIOUS/EXPECTED FOR ALLERGIC REACTION TO EXCIPIENT (PROPYLENE GLYCOL) AS A PROVEN HYPERSENSITIVITY TO A COMPONENT OF THE PRODUCT AND SERIOUS/UNEXPECTED FOR VAGINAL BLEEDING AND URINARY TRACT INFECTION SINCE THEY ARE NOT LISTED IN THE LABEL OF THE PRODUCT. THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS DEFINITE FOR ALLERGIC REACTION TO EXCIPIENT, AS POSSIBLE FOR VAGINAL BLEEDING, SINCE THE EVENT COULD BE LIKELY RELATED TO THE EXTREME VAGINAL DRYNESS OF THE PATIENT, AND AS POSSIBLE FOR URINARY TRACT INFECTION. IN FACT, THERE IS A TEMPORAL RELATIONSHIP BETWEEN THE USE OF HYALOGYN AND THE ONSET OF THE URINARY TRACT INFECTION BUT THERE IS NO SCIENTIFIC GROUNDS TO RELATE THE INFECTION TO THE PRODUCT. THE BATCH NUMBER IS NOT CURRENTLY AVAILABLE FOR AN INVESTIGATION. IF NEW INFORMATION COME TO LIGHT, THE CASE WILL BE RE-EVALUATED. THE CONDITION OF MEDICATION ERROR IS NOT ASSESSABLE.

    Description of Event or Problem · 0

    THIS IS A SERIOUS, SPONTANEOUS ADVERSE EVENT REPORTED BY A (B)(6) FEMALE CONSUMER INVOLVING HYALOGYN. IT IS NOT A MEDICAL CONFIRMED CASE. THE PATIENT IS ON NO MEDICATIONS EXCEPT THE ANTIBIOTIC MACRABID WHICH WAS PRESCRIBED AS A RESULT OF THIS ADVERSE EVENT. THE CONSUMERS GYNECOLOGIST RECOMMENDED SHE TRY HYALOGYN FOR EXTREMELY DRY VAGINA. THE CONSUMER PREFERS TO USE ONLY ALL NATURAL PRODUCTS DUE TO ALLERGIES, WHICH IS WHY HER PHYSICIAN RECOMMENDED HYALOGYN. SHE PURCHASED THE PRODUCT AND APPLIED IT INTRAVAGINALLY AS INDICATED IN THE LABELING ON (B)(6) 2019. THE CONSUMER REPORTED THAT SHE INITIALLY EXPERIENCED SOME INITIAL BURNING, DISCOMFORT AND IRRITATION BUT INITIALLY DISMISSED IT DUE TO THE EXTREME DRYNESS OF THE VAGINAL TISSUE. THE PAIN, BURNING AND IRRITATION INCREASED OVER THE NEXT TWO DAYS. SHE ALSO BEGAN TO EXPERIENCE SOME MILD BLEEDING. SHE CONTACTED HER GYNECOLOGIST ON (B)(6) 2019 AND WAS IMMEDIATELY SEEN IN THE CLINIC. THE PHYSICIAN PERFORMED A PHYSICAL EXAM, NOTED THAT THE VAGINA WAS IRRITATED AND RED. A URINE SPECIMEN WAS TESTED AND WAS POSITIVE FOR A URINARY TRACT INFECTION. THE PATIENT DID NOT USE THE PRODUCT AGAIN AND THE PHYSICIAN PRESCRIBED THE ANTIBIOTIC MACROBID FOR A SEVEN DAY REGIMEN. THE PATIENT FINISHED THE ANTIBIOTIC, TAKING HER LAST DOSE ON (B)(6) 2019. SHE WILL RETURN TO THE PHYSICIAN'S OFFICE ON (B)(6) 2019 FOR A FOLLOW-UP EXAM. AT THE TIME OF THIS REPORT THE CONSUMER'S SYMPTOMS HAD IMPROVED. SHE NO LONGER FEELS ANY PAIN, BLEEDING, BURNING OR IRRITATION OF THE VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315785 HYALOGYN HYALOGYN VAGINAL HYDRATING GEL NUC FIDIA FARMACEUTICI S.P.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other