BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ Q/STAY SAFE CYCLER SET

    MDR report key: 3874864 · Received June 2, 2014

    Report

    Report Number
    8030665-2014-00458
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    REYNOSA MFG
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. THE RELATED MDRS #2937457-2014-00915, 1713747-2014-99977, AND 8030665-2014-00458.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS ADMITTED TO THE HOSP ON (B)(6) 2014 DUE TO TESTICULAR SWELLING DURING TREATMENT. DURING THE ADMISSION, THE PT WAS DIAGNOSED WITH AN INGUINAL HERNIA, HAD HERNIA SURGERY, AND WAS DISCHARGED ON (B)(6) 2014. ACCORDING TO THIS NURSE, THE PT'S COMPLAINT OF TESTICULAR SWELLING HAS RESOLVED, NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED. AS OF (B)(6) 2014, THE PT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321054 NEWTON IQ Q/STAY SAFE CYCLER SET KDJ REYNOSA MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR