BEUDAMED
    FDA Adverse Event Injury Summary report: N

    08290-8418-01

    MDR report key: 2771649 · Received September 27, 2012

    Report

    Report Number
    MW5027116
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MULTIHOUR ERECTION WITH NO EJACULATION, EXTREME PAIN, BLACKENED WHITE SKIN OF PENIAL GLAD. MD SOLD "TRIMIX" RX (B)(4) HAS TWO REFILLS 30MG/0.5MG/10MCG OF BALANCED SOLUTIONS (B)(6). MD WITH NO ANTIDOTE FOR PRODUCT AND OUT TO LUNCH WHEN ADVERSE SITUATION OCCURRED. PT SERVICED AT (B)(6) EMERGENCY ROOM BY (B)(6) PHARMACIST. (B)(6). HAS GLAND STITCHES TO BE REMOVED UPCOMING SATURDAY FROM AREAS THAT WHERE INTERVENED. TWO REFILLS: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 08290-8418-01 INSULIN SYRINGES W BD ULTRA FINE NEEDLE FMF BECTON DICKINSON 328418

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening SERTRALINE 100MG| LOSARTAN 100MG| NYQUIL| EXP DATE 11/04/2012| MULTIVITAMIN| FISH OIL| TRAZODONE 100MG| AMLODIPINE 5MG| GLYNASE 6MG| OTHERS| SUDAFED 120MG| AMITRIPTILINE 25MG| IBUPROFEN 800MG| ALPRAZOLAM 2MG| TRIMIX STANDARD 30MG/0.5MG/10MCG: LOT 0112012 @ 10| ACETAMINOPHEN 500MG| NUTRIENTS FROM HEALTH FOOD (B)(4)