BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONECT CREAM 25G TUBE

    MDR report key: 4088185 · Received September 2, 2014

    Report

    Report Number
    3005536974-2014-00001
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    March 3, 2013
    Report Date
    August 13, 2014
    Manufacturer
    INNOCUTIS
    Product Code
    MGQ
    PMA / PMN Number
    K963004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED IN THIS REPORT IS BASED ON SELF-REPORTED STATEMENTS PROVIDED TO THE MANUFACTURER DURING A TELEPHONE INTERVIEW. THESE SELF-REPORTED DESCRIPTIONS OF AN INCIDENT HAVE NOT BEEN INDEPENDENTLY VERIFIED TO BE FACTUALLY CORRECT OR COMPLETE DESCRIPTIONS OF THE INCIDENT. FOR THAT REASON, INFORMATION CONTAINED IN THIS REPORT DOES NOT AND CAN NOT FORM THE BASIS FOR A DETERMINATION OF WHETHER THE REPORT CLINICAL EFFECTS ARE CAUSALLY RELATED OR ASSOCIATED WITH AN EXPOSURE TO THE PRODUCT IDENTIFIED IN THE TELEPHONE INTERVIEW. THE INFORMATION PROVIDED IN THIS REPORT HAS NOT BEEN MEDICALLY VERIFIED VIA CONFIRMATION WITH THE PATIENT'S PHYSICIANS OR BY THE PROVISION OF PATIENT MEDICAL RECORDS. WHEN CONSIDERING THE BODY OF REGULATORY DATA AND POST-MARKETING DATA AS WELL AS THE WRIGHT OF SCIENTIFIC PEER REVIEWED EVIDENCE ON TOPICALLY APPLIED HYALURONATE CONTAINING PRODUCT SUCH A CAUSAL RELATIONSHIP BETWEEN THE USE OF THIS TYPE OF DEVICE AND THE DEVELOPMENT OF THE ADVERSE EFFECTS REPORTED IN THIS CASE CANNOT BE DEFINITIVELY ESTABLISHED. WHEN EVALUATING A PATIENT FOR A POTENTIAL HYPERSENSITIVITY (ALLERGIC) REACTION, A CLINICAL PRACTITIONER MUST CONSIDER SEVERAL POTENTIAL ENVIRONMENTAL ETIOLOGIES AS WELL AS ANY GOODS, BEVERAGES, MEDICATIONS, OR DIETARY SUPPLEMENTS THE PATIENT HAD BEEN TAKING JUST PRIOR TO THE ONSET OF SYMPTOMS. DEFINITIVE CAUSALITY CANNOT BE APPLIED TO ANY ONE COMPOUND OR AGENT WITHOUT VERIFICATION.

    Description of Event or Problem · 1

    THIS SPONTANEOUS EVENT WAS RECEIVED BY PHONE ON (B)(6) 2013. CALLER WISHES TO KNOW IF PRODUCT IS TO MAKE SKIN MORE RED AND IF YOU GET ANY BENEFITS FROM APPLYING IT 1 TIME DAILY. CALLER STATES SHE HAS BEEN APPLYING IT 3 TIMES DAILY. CALLER WAS PUT ON THE BIONECT CREAM FROM HER DOCTOR BUT THEN SWITCHED TO USING THE GEL. CALLER REPORTED THAT SHE STARTED TO USE THIS ABOUT 3 WEEKS AGO (APPLYING TWICE DAILY) AT THE DIRECTION OF HER DERMATOLOGIST. SHE IS ATTEMPTING TO MANAGE ROSACEA BUT HAS BEEN TRYING A NUMBER OF DIFFERENT COMBINATIONS OF OTC AND RX PRODUCTS. SHE THINKS THAT THIS WAS SOMEWHAT WORSENING THE ISSUE FOR A FEW DAYS (SKIN WAS BECOMING MORE RED AND IRRITATED THAT PREVIOUS) BUT IS TRYING TO UNDERSTAND ITS OVERALL ROLE IN THERAPY. SHE WAS INFORMED THAT SKIN CONDITION TYPICALLY IS FAIRLY COMPLICATED FOR MANY PATIENTS AND MAY REQUIRE FREQUENT CHANGES IN DRUG THERAPY FOR SOME PEOPLE. THIS PRODUCT IS DESIGNED TO HELP PROTECT THE SKIN FROM WORSENING INJURY THOUGH SHOULD NOT "PROMOTE" OR WORSEN THAT ISSUE PER SE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533051 BIONECT CREAM 25G TUBE HYALURONATE SODIUM MGQ INNOCUTIS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other