BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NU-GEL¿ HYDROGEL WITH ALGINATE

    MDR report key: 9147893 · Received October 2, 2019

    Report

    Report Number
    3007663067-2019-00004
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    August 24, 2019
    Report Date
    October 2, 2019
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED PAIN, REACTION, AND POTENTIAL INFECTION ARE RELATED TO THE NU-GEL¿ HYDROGEL. KCI/SYSTAGENIX DETERMINED THE PLANNED SURGERY AND PREVIOUS GRAFT LOSS WERE DEEMED NOT RELATED TO NU-GEL¿ HYDROGEL. DEVICE LABELING, AVAILABLE IN PRINT STATES: INDICATIONS: NU-GEL¿ HYDROGEL IS A TRANSPARENT HYDRO ACTIVE AMORPHOUS GEL CONTAINING SODIUM ALGINATE. THE HYDROGEL CREATES A MOIST WOUND HEALING ENVIRONMENT WHICH ASSISTS WITH NATURAL AUTOLYTIC DEBRIDEMENT WHILST THE ALGINATE COMPONENT ENHANCES ITS ABSORPTIVE CAPABILITIES. THE GEL CAN BE USED TO SOFTEN AND HYDRATE ESCHAR BY FACILITATING REHYDRATION OF THE WOUND. NU-GEL¿ HYDROGEL IS INDICATED FOR DEBRIDEMENT AND DESLOUGHING OF WOUNDS TOGETHER WITH THE MANAGEMENT OF CHRONIC WOUNDS THROUGHOUT ALL STAGES OF THE HEALING PROCESS. [DEVIATION FOR SPANISH: NU-GEL¿ HYDROGEL IS INDICATED FOR THE TREATMENT OF DECUBITUS ULCERS AND VARICOSE IN ALL STATES OF HEALING. PRECAUTIONS: IF WOUND INFECTION DEVELOPS, APPROPRIATE ANTIMICROBIAL THERAPY SHOULD BE INITIATED. THE USE OF NU-GEL¿ HYDROGEL MAY BE CONTINUED UNDER MEDICAL SUPERVISION. NU-GEL¿ HYDROGEL CONTAINS PROPYLENE GLYCOL WHICH MIGHT CAUSE IRRITATION OR SENSITISATION IN A SMALL NUMBER OF PATIENTS; IF SUCH REACTIONS ARE NOTED, USE OF NU-GEL¿ HYDROGEL SHOULD BE DISCONTINUED. .

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI/SYSTAGENIX BY THE PATIENT'S DAUGHTER: THE PATIENT WAS POST OPERATIVELY USING THE NU-GEL¿ HYDROGEL WITH ALGINATE FOR A FEW DAYS AND ALLEGEDLY EXPERIENCED SIGNIFICANT PAIN AFTER PRODUCT USE. ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI/SYSTAGENIX BY THE PATIENT'S DAUGHTER: ON (B)(6) 2019, THE PATIENT ALLEGEDLY EXPERIENCED A REACTION. THE PATIENT REPORTEDLY HAS NO KNOWN ALLERGIES TO THE NU-GEL¿ HYDROGEL INGREDIENTS. THE PHYSICIAN ADVISED THE PATIENT TO STOP THE TREATMENT, AND ALLEGEDLY BELIEVES THERE IS AN INFECTION PRESENT. THE PHYSICIAN HAS STARTED THE PATIENT ON AN ANTIBIOTIC REGIMEN. 10 PLUS BOTTLES OF THE NU-GEL¿ HYDROGEL WERE ALLEGEDLY ASSOCIATED WITH THIS ADVERSE REACTION. THE REACTION AND POTENTIAL INFECTION HAVE BEEN REVIEWED AND ARE PROCEEDING WITH PLANNED SURGERY. ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI/SYSTAGENIX BY THE PHYSICIAN: THE REPORTED PLANNED SURGERY WAS NOT RELATED TO NU-GEL¿ HYDROGEL. THE PATIENT EXPERIENCED A PREVIOUS 20% GRAFT LOSS WHICH WAS REPLACED ON (B)(6) 2019. THE NEW GRAFT IS REPORTEDLY HEALING WELL AS OF (B)(6) 2019. NO ADDITIONAL INFORMATION IS AVAILABLE. KCI/SYSTAGENIX HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN THE DEVICE IDENTIFIER, AND THE PRODUCT WAS NOT RETURNED. THEREFORE, A DEVICE EVALUATION AND DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941210 NU-GEL¿ HYDROGEL WITH ALGINATE NAD NAD SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD NU-GEL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention