BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER MEDICAL

    MDR report key: 830354 · Received March 5, 2007

    Report

    Report Number
    2130787-2007-00001
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 5, 2007
    Manufacturer
    ROCHESTER MEDICAL
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES HE HAS USED ROCHESTER MEDICAL ANTIBACTERIAL INTERMITTENT CATHETER (ITEM # 63914) FOR 5 YRS. IN THE LAST YEAR, HE STATES HE HAS HAD SOME CATHETERS WITH A SHARP EDGE ON THEM. HE STATES THAT HE HAS BEEN SEEN IN THE ER AND BY HIS UROLOGIST 2 TIMES WITH INTERNAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHESTER MEDICAL ANTIBACTERIAL INTERMITTENT URINARY CATH EXJ ROCHESTER MEDICAL 63914 53603361

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention