BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOVERA

    MDR report key: 11392022 · Received February 26, 2021

    Report

    Report Number
    MW5099677
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    May 10, 2019
    Report Date
    February 24, 2021
    Manufacturer
    MYOSCIENCE INC./PACIRA PHARMACEUTICALS, INC
    Product Code
    GXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALTERED SENSATION REMAINING; I HAD IOVERA FOR A KNEE REPLACEMENT. I STILL HAVE NOT REGAINED NORMAL SENSATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281119 IOVERA DEVICE, SURGICAL, CRYOGENIC GXH MYOSCIENCE INC./PACIRA PHARMACEUTICALS, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other