BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 271 · Received March 5, 1992

    Report

    Report Number
    271
    Event Type
    Injury
    Date Received
    March 5, 1992
    Date of Event
    January 28, 1992
    Report Date
    February 24, 1992
    Manufacturer
    UNKNOWN
    Product Code
    EZK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HAVE CUFF OF CAPD CATHETER DEBRIDED;HAS INFECTION AROUND EXIT SITE OF CATHETER. CUFF TO BE DEBRIDED IN ATTEMPT TO SALVAGE CATHETER. PATIENT HAS BEEN ON CHRONIC ANTIBODICS IN ATTEMPT TO CONTROL INFECTION. TIP OF CUFF IS VISABLE THROUGH THE SKINDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CAPD CATHETER EZK UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other