BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANDROGEL GEL PUMP 1% 75GM; 12.5MG LBI (UNIMED)

    MDR report key: 1729581 · Received June 15, 2010

    Report

    Report Number
    MW5016421
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 9, 2010
    Manufacturer
    LBI (UNIMED)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES HE HAS HAD SEVERAL DEFECTIVE ANDROGEL PUMPS. HE EXPERIENCED 3 DEFECTIVE PUMPS OUT OF THE LAST 3 ORDERS (FILLS). PATIENT SAID THE PUMP WOULD NOT DISPENSE MED. DOSE, FREQUENCY AND ROUTE USED; APPLY 4 PUMPS (5 GRAMS) DAILY. THERAPY DATES: (B) (6) 2010 TO (B) (6). DIAGNOSIS FOR USE: TESTOSTERONE REPLACEMENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANDROGEL GEL PUMP 1% 75GM; 12.5MG LBI (UNIMED) NONE FRN LBI (UNIMED) 70714
    2 ANDROGEL GEL PUMP 1% 75GM; 12.5MG LBI (UNIMED) NONE FRN 70720
    3 ANDROGEL GEL PUMP 1% 75GM; 12.5MG LBI (UNIMED) NONE FRN 70677

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR FLOMAX CAPS 0.4MG (B) (6)| ACEON TABS 4MG (B) (6)| ZETIA TABS 10MG (B) (6)