BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM 21S

    MDR report key: 2855517 · Received September 27, 2012

    Report

    Report Number
    2410375-2012-00003
    Event Type
    Injury
    Date Received
    September 27, 2012
    Report Date
    September 25, 2012
    Product Code
    NPZ
    PMA / PMN Number
    P040013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A SPONTANEOUS REPORT WAS RECEIVED BY LUITPOLD PHARMACEUTICALS, INC. INVOLVING GEM 21S AND AN UNSPECIFIED PT. DURING F/U TO A PREVIOUSLY REPORTED ADVERSE REACTION INVOLVING GEM 21S ((B)(4)), A DENTAL PROVIDER REPORTED A SECOND HAND ACCOUNT THAT HER COLLEAGUE STATED HE HAD A PT WHO HAD EXPERIENCED "SYMPTOMS SIMILAR TO FLESH EATING BACTERIA" ((B)(6) CODED: BACTERIAL INFECTION NOS). SHE STATED HER COLLEAGUE USED GEM 21S OFF LABEL WITH THIS PT ((B)(6) CODED: OFF LABEL USE). NO ADDITIONAL INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFO RECEIVED (B)(6) 2012 FROM REPORTING (NON-TREATING) DENTAL PROVIDER: AFTER MULTIPLE REQUESTS TO THE REPORTER FOR THE NAME AND CONTACT INFO OF TREATING DENTIST, THE REPORTER RESPONDED THAT SHE WOULD NOT BE PROVIDING THE REQUESTED INFO, CITING "DOCTOR TO DOCTOR CONFIDENTIALITY," AND STATED THAT "MY COLLEAGUE ASSURED ME THAT HE SPOKE WITH YOUR COMPANY." NO ADDITIONAL INFO WAS PROVIDED, AND ON THE BASIS OF THIS RESPONSE, ADDITIONAL INFO WAS NOT EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM 21S NONE NPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention