BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PORT PORTA CATH

    MDR report key: 84933 · Received July 1, 1996

    Report

    Report Number
    84933
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    June 1, 1996
    Report Date
    June 28, 1996
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING LAST CHEMO TREATMENT, SHE DEVELOPED ERYTHEMA IN AREA ABOUT HER PORT SITE, WAS SEEN ON DAY THREE OF THE LAST CYCLE. ORAL ANTIBIOTIC GIVEN WITH SOME IMPROVEMENT. HOWEVER SEEN 12 DAYS LATER WITH WORSENING ERYTHEMA AND INDURATION OVER PORT SITE. IMPRESSION - POSS. CHEMO INFILTRATE. ADMITTED TO HOSP WITH POSS. PORT SITE EXTRAVASATION. R/O SEPSIS AND PORT INFECTION. PORT REMOVED 6/20/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PORT PORTA CATH Implant PORTA CATH LJT STRATO MEDICAL CORP LPS 7513 12824

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R