BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 4044900 · Received August 26, 2014

    Report

    Report Number
    9617083-2014-00033
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K021551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: THIS WAS A PHYSICIAN DIRECTED USE. MIXING WITH OTHER SUBSTANCES IS AN OFF-LABEL USE IN THE USA. IN CASES PREVIOUSLY DOCUMENTED WHERE HIGH LEVELS OF VANCOMYCIN AND TOBRAMYCIN HAVE BEEN ADMINISTERED, THE PT HAS ACUTE KIDNEY INJURY. VANCOMYCIN AND TOBRAMYCIN ARE DOCUMENTED TO BE NEPHROTOXIC. ACUTE KIDNEY INJURY MAY CONTRIBUTE TOWARDS HYPERCALCEMIA.

    Description of Event or Problem · 1

    PT ADMITTED FRIDAY, (B)(6) 2014 FOR INFECTED KNEE. AS PART OF THE TREATMENT, THE SURGEON ELECTED TO MIX 1G VANCOMYCIN AND 1.2G TOBRAMYCIN WITH 10CC STIMULAN RAPID CURE. OVER THE WEEKEND ((B)(6) 2014), THE PT PRESENTED WITH HYPERCALCEMIA. PT HISTORY DETAILS: PT WAS ON VANCOMYCIN IV PRE-OPERATIVELY AND AT DISCHARGE AND GOT ONE DOSE OF ANCEF AT SURGICAL INDUCTION. PT'S VANCOMYCIN TROUGH WAS 13.8 PRE-OPERATIVELY (NORMAL) AND 17.2 AT POST-OPERATIVE DAY 8. PT HAD NO HISTORY OF RENAL DYSFUNCTION OF CALCIUM DISORDERS PRE-OPERATIVELY. SHE HAS A HISTORY OF RENAL STONES OF UNK TYPE. PT'S BUN/CREATINE WAS 7/0.7 PRE-OPERATIVELY AND WERE 8/1.0 AT DISCHARGE. SERUM CALCIUM LEVEL AT INITIAL ADMISSION WAS 9.2. IT ROSE TO 12.3 ON POST-OP DAY #2. AT DISCHARGE IT WAS 8.6. ON POST-OP DAY #2 THE PT WAS GIVEN CALCITONIN AND PAMIDRONATE. MOST OF THE STIMULAN BEADS APPEAR TO HAVE RESORBED ON RADIOGRAPHS. THE PT IS DOING BETTER, HOWEVER, INFECTION WILL CONTINUE TO BE MONITORED. OTHER DEVICES / SUBSTANCES USED:1G VANCOMYCIN AND 1.2G TOBRAMYCIN, IV VANCOMYCIN, 1 DOSE ANCEF. ICU: CALCITONIN, PAMIDRONATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516337 STIMULAN RAPID CURE BONE VOID FILLER / GRAFT EXTENDER MQV BIOCOMPOSITES LTD. 12/13-R205

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization