BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAFLEX

    MDR report key: 19104962 · Received April 12, 2024

    Report

    Report Number
    MW5153837
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 10, 2024
    Report Date
    April 10, 2024
    Manufacturer
    TEPHA, INCORPORATED
    Product Code
    OOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GALAFLEX ALMOST KILLED ME. TWICE. I NEVER KNEW IT WAS NOT APPROVED BY THE FDA.I HAD TO HAVE TWO SURGERIES AND CONTRACTED CLOSTRIDIOIDES DIFFICILE FROM THE AMOUNT OF THE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582175 GALAFLEX SURGICAL FILM OOD TEPHA, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability| R| O| H| L HYDROCODONE 7.5 MG, 2-3 TIMES A DAY AS NEEDED FOR PAIN.| VYVANSE, ONE TIME A DAY.