BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPORT ARRAY

    MDR report key: 3896249 · Received June 20, 2014

    Report

    Report Number
    MW5036818
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BLACKROCK MICROSYSTEMS
    Product Code
    GZL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PARTICIPANT REPORTED ON (B)(6) 2014 HAVING A SUPRAPUBIC CATH MALFUNCTION RESULTING HEMATURIA, UTI ASSOCIATED WITH FEVERS, FATIGUE, AND INCREASE IN SPASM. HE PRESENTED TO OUTSIDE ED WHERE HE WAS GIVEN ANTIBIOTICS AND DISCHARGE HOME. PARTICIPANT WAS SEEN (B)(6) 2014 FOR FOLLOW UP, HE STATES HE STILL DOES NOT FEEL WELL. HE DENIES FEVER BUT CONTINUES TO HAVE MUSCLE SPASMS AND CHILLS. HE DENIES ABDOMINAL PAIN, FLANK PAIN, POSITIVE FOR MUSCLE SPASM AND SHOULDER ACHES. HE CHANGED HIS SUPRAPUBIC CATHETER AND REPORTED NO PROBLEMS WITH IT. UTI CONCERN FOR SEEDING OF THE PEDESTAL/DEVICE IMPLANT SITE DUE TO FEVER FOR THE PAST 4-5 DAYS AND POSSIBLE UNDER TREATMENT OF UTI. PARTICIPANT WAS ADMITTED TO THE HOSPITAL FROM THE CLINIC ON (B)(6) 2014 FOR FURTHER MANAGEMENT AND TREATMENT OF HIS UTI WITH IV ANTIBIOTICS, IV HYDRATION, INFECTIOUS DISEASE CONSULT, AND UROLOGY CONSULT TO EVALUATE SUPRAPUBIC CATHETER. HE WAS INITIATED ON ANTIBIOTICS, INFECTIOUS DISEASE WAS CONSULTED FOR MANAGEMENT OF ANTIBIOTICS. HIS BLOOD CULTURE WERE NEGATIVE AND HE WAS CHANGED TO ORAL ANTIBIOTICS ON (B)(6) 2014. UROLOGY WAS CONSULTED AND THE SUPRAPUBIC CATHETER WAS CHANGED ON ADMISSION TO THE HOSPITAL. PARTICIPANT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2014 AND ON ANTIBIOTICS. PEDESTAL/DEVICE IMPLANT SITE IS HEALING WELL, AND NO EVIDENCE OF INFECTION. PARTICIPANT WAS FOLLOW-UP ON (B)(6) 2014 AND REPORTED TO BE FEELING WELL AND HAS BEEN ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364062 NEUROPORT ARRAY NEUROPORT ARRAY GZL BLACKROCK MICROSYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization