BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN RAPID CURE 20CC 620-020

    MDR report key: 9481960 · Received December 17, 2019

    Report

    Report Number
    9617083-2019-00005
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    September 16, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    UDI-DI
    50601557110416
    PMA / PMN Number
    1065982
    Removal / Correction Number
    MW5089948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    FDA REPORT MW5089948 HAS BEEN SUBMITTED RELATING TO A PATIENT WITH HYPERGLYCEMIA WITH A CALCIUM LEVEL OF 13.9 (REF RANGE 8.3 -10.) BIOCOMPOSITES LTD HAVE A RISK ASSESSMENT FOR HYPERCALCEMIA RELATED EVENTS WITH THE USE OF STIMULAN PRODUCTS, RISK - 00364 STATES: "USE IN PATIENTS WITH HYPERCALCEMIA IS CONTRAINDICATED. RISK CONTROL MEASURES NOT POSSIBLE AS USE IN PATIENTS WITH A PRE-EXISTING CALCIUM METABOLISM DISORDER IS UNDER DIRECTION OF THE OPERATING SURGEON. RECOMMENDED ACTIONS: NONE REQUIRED. ADDITIONAL RISKS CREATED: NO ADDITIONAL RISK FORESEEN. RESIDUAL RISK: THE RESIDUAL RISK OF EXACERBATED SYMPTOMS ASSOCIATED WITH HYPERGLYCAEMIA REQUIRING INTERVENTION IS BROADLY ACCEPTABLE. RISK/BENEFIT ANALYSIS: THE RESIDUAL RISK OF EXACERBATED SYMPTOMS ASSOCIATED WITH HYPERCALEMIA REQUIRING INTERVENTION IS OUTWEIGHED BY THE CLINICAL BENEFIT OF USING THE DEVICE."

    Description of Event or Problem · 1

    PT EXPERIENCED HYPERCALCEMIA, WITH A CALCIUM LEVEL OF 13.9 (REF RANGE 8.3 - 10.4).FDA SAFETY REPORT ID#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272425 STIMULAN RAPID CURE 20CC 620-020 FILLER, BONE VOID, CALCIUM COMPOUND MQV BIOCOMPOSITES LTD. 620-020 SR190508 50601557110416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other