BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE 48 MG

    MDR report key: 14575601 · Received June 1, 2022

    Report

    Report Number
    MW5110040
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 27, 2022
    Report Date
    May 28, 2022
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SYNVISC ONE, LOWER PORTION OF GLASS TUBE UNDER PLASTIC HAND FRACTURED, BROKE APART AND FELL ONTO FLOOR, DID NOT CAUSE PUNCTURE WOUND TO PROVIDER OR PATIENT. LOT NUMBER BRSL039D, EXP DATE: 09/2024. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27142 SYNVISC ONE 48 MG ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION BRSL039D

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male