BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 3775739 · Received April 14, 2014

    Report

    Report Number
    9617083-2014-00013
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    January 25, 2014
    Report Date
    March 20, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MBP
    PMA / PMN Number
    K021551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: SERUM CREATINE (A BLOOD MEASUREMENT) IS AN IMPORTANT INDICATOR OF RENAL HEALTH BECAUSE IT IS AN EASILY MEASURED BYPRODUCT OF MUSCLE METABOLISM THAT IS EXCRETED UNCHANGED BY THE KIDNEYS. A SERUM CREATININE OF 1.2MG/DL (110MCG/L) CAN INDICATE SIGNIFICANT RENAL DISEASE AND SYSTEMIC TOXICITY IN AN ELDERLY FEMALE, AS THE KIDNEY FUNCTION IS DEPLETED. CERTAIN DRUGS CAN SOMETIMES CAUSE ABNORMALLY ELEVATED CREATININE LEVELS. ANTIBIOTICS WERE DELIVERED IV- THERE IS NO LINK ESTABLISHED TO SYSTEMIC LEVELS FROM LOCAL DELIVERY. THE PATIENT'S READING HAD INCREASED FROM 1 - NORMAL TO 1.8 - HIGH. SUSPECTED ROOT CAUSE OF HIGH CREATININE LEVEL IS ASSOCIATED WITH RENAL FAILURE, NOT STIMULAN RAPID CURE, WHICH IS CONTRAINDICATED FOR RENAL COMPROMISED PATIENTS.

    Description of Event or Problem · 1

    FROM A MAUDE EVENT REPORT RECEIVED AT BIOCOMPOSITES INC ON (B)(4) 2014 FROM THE FDA: VOLUNTARY REPORT NO.: (B)(4) HAD BEEN RECEIVED AT FDA VIA THEIR MEDWATCH PROGRAM. FDA HAD FORWARDED THE DETAILS TO BIOCOMPOSITES INC. FOR REVIEW, AS MAY HAVE BEEN UNAWARE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228321 STIMULAN RAPID CURE BONE VOID FILLER/ GRAFT EXTENDER MBP BIOCOMPOSITES LTD. 08/13-R192

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization