BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANSER, WOUND (CLEANSER, WOUND GENTELL SPRAY, TOP)

    MDR report key: 10507464 · Received September 8, 2020

    Report

    Report Number
    MW5096484
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    December 5, 2017
    Report Date
    February 16, 2018
    Manufacturer
    GENTELL
    Product Code
    NAE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NARRATIVE: PATIENT EXPERIENCED HYPOTENSION AND HIVES S/P WOUND CARE APT WHICH INVOLVED USE OF WOUND CLEANSER. PATIENT REQUIRED EPI, SOLUMEDROL, DIPHENHYDRAMINE, IVF BOLUS. SINCE PATIENT USES STERILE SALINE FOR WOUND CARE AT APT. SYMPTOMS: HYPOTENSION; ANAPHYLAXIS TREATMENT DRUGS USED: CLEANSER, SKIN (GENTLE SKIN CLEANSER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964860 CLEANSER, WOUND (CLEANSER, WOUND GENTELL SPRAY, TOP) DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE GENTELL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R