BEUDAMED
    FDA Adverse Event Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 5009703 · Received August 18, 2015

    Report

    Report Number
    9617083-2015-00001
    Date Received
    August 18, 2015
    Date of Event
    July 19, 2015
    Report Date
    July 21, 2015
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    UDI-DI
    50601557110270
    PMA / PMN Number
    K141830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PATIENT CO-MORBIDITY: PRIOR DOUBLE MASTECTOMY, RADIATION. PATIENT HAS ALLERGIES TO KEFLEX, DARVOCET, PERCOCET, XELODA, AFFINITOR, TOPICALS CONTAINING SULFA/SULFITE, SUCH AS COMMERCIALLY AVAILABLE SHAMPOO/SOAP. THE SURGEON CONFIRMED SURGERY WAS PERFORMED USING STIMULAN AND A CURETTE WAS USED TO REMOVE THE STIMULAN. AT THIS POINT, THE STIMULAN WAS MOSTLY DISSOLVED AND LOOKED LIKE A LIME PASTE ON THE TISSUE, WITH A WHITE, FIBRIN MATERIAL THAT COMMONLY EXISTS WITHIN THE SURGICAL POCKET BEFORE THE TISSUE HAS A CHANCE TO HEAL AND SCAR OVER. THE SURGEON SAID IT IS NORMAL, EVEN WITHOUT A PRODUCT PRESENT IN THE AREA, AND THAT IT IS A RESULT OF BLOOD BREAKDOWN. THE PATIENT ALSO RECEIVED A LARGE BOLUS OF STEROIDS AND BY THE TIME THE SURGICAL DRAPES WERE OFF, THE PATIENT'S HIVES WERE GONE. AT THE TIME OF PATIENT FOLLOW UP, THE PATIENT CONDITION WAS SATISFACTORY. THE SURGEON DOES NOT ATTRIBUTE THE ALLERGY TO STIMULAN, BUT POSSIBLY TO THE GENTAMICIN OR VANCOMYCIN THAT WERE COMBINED WITH THE STIMULAN. THE PATIENT HAS KNOWN SULFA AND SULFITE ALLERGIES, HOWEVER, THE SURGEON HAS EXPLAINED THAT SULFA/SULFITE/SULFATE ARE ALL CHEMICALLY DIFFERENT AND THE SURGEON DID NOT SUSPECT STIMULAN TO BE THE CAUSE OF THE REACTION. THE SURGEON HAS ADDED TO THE PATIENT'S RECORD OF ALLERGIES: STIMULAN, VANCOMYCIN, GENTAMICIN. OTHER SUBSTANCES USED: JP DRAIN, CLINDAMYCIN, EXTRA STRENGTH TYLENOL, GENTAMICIN, VANCOMYCIN, BENADRYL, ZANTAC. THE SURGEON IS AN EXPERIENCED STIMULAN USER. SUSPECTED ROOT CAUSE: POSSIBLE ALLERGY TO EITHER STIMULAN, VANCOMYCIN, OR GENTAMICIN OR OTHER POTENTIAL ALLERGENS. CORRECTIVE ACTION: SURGERY WAS UNDERTAKEN TO REMOVE THE STIMULAN ON (B)(6) 2015 (11 DAYS POST IMPLANTATION).

    Description of Event or Problem · 1

    (B)(6) 2015: PATIENT UNDERWENT AN EXCISION BIOPSY OF TWO LARGE TUMORS IN THE LEFT ANTERIOR AXILLA, WITH PRIMARY CLOSURE, AND A JP DRAIN. A 5CC OF STIMULAN RAPID CURE MIXED WITH VANCOMYCIN AND GENTAMICIN WAS IMPLANTED DUE TO PATIENT'S PRIOR WOUND HEALING ISSUES AND PREVIOUS INFECTIONS. THE PATIENT RECEIVED THREE IV DOSES OF CLINDAMYCIN AND ONE EXTRA STRENGTH TYLENOL POST-OP. CLEAN MARGINS WERE OBTAINED ON THE BIOPSIES. THE PATIENT DID NOT HAVE ANY MEDICATION CHANGES PRE/POST-OP, NOR DID SHE RECEIVE ANY MEDICATIONS IN THIS PERIOD THAT SHE HAD NOT TAKEN PREVIOUSLY. (B)(6) 2015: PATIENT WAS ASYMPTOMATIC AND HAS NOT REQUIRED ANY ADDITIONAL PAIN MEDICATION. (B)(6) 2015: PATIENT DEVELOPED ITCHING AROUND THE SURGICAL SITE. (B)(6) 2015: THE PATIENT'S SYMPTOMS PROGRESSED TO A SYSTEMIC ALLERGIC REACTION. THE PATIENT VISITED HER PRIMARY CARE PHYSICIAN AND BEGAN TAKING H1/H2 BLOCKERS (BENADRYL AND ZANTAC). THE PATIENT INCREASED HER BENADRYL AND SYMPTOMS WORSENED. WHEN THE PATIENT REPORTED TONGUE SWELLING, THE SURGEON RECOMMENDED SHE COME BACK IN TO BE SEEN. (B)(6) 2015: THE PATIENT WAS DIAGNOSED IN THE ER WITH SERUM SICKNESS/LOW GRADE REACTION TO AN UNKNOWN CAUSE. THERE IS NO ANAPHYLACTIC REACTION. THE SURGEON PLANS TO START THE PATIENT ON STEROIDS TO CONTROL THE ALLERGIC REACTION AND ALSO PLANS TO WASHOUT THE STIMULAN AS A PRECAUTIONARY MEASURE, SINCE THE PATIENT HAS SO MANY SENSITIVITIES. THE SURGEON SUGGESTED THE ALLERGIC REACTION MAY BE PRESENTING SO LATE DUE TO POOR TISSUE VASCULARIZATION RESULTING FROM PRIOR SURGERIES/RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545926 STIMULAN RAPID CURE BONE VOID FILLER / GRAFT EXTENDER MQV BIOCOMPOSITES LTD 03/15-R232 50601557110270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GENTAMICIN