BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL, INC.

    MDR report key: 3099 · Received January 6, 1992

    Report

    Report Number
    3099
    Event Type
    Malfunction
    Date Received
    January 6, 1992
    Manufacturer
    BARD
    Product Code
    HCA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD HER PORT-A-CATH REMOVED ON 5/9/92. ON 5/22/92 THE PATIENT REQUIRED SURGICAL REMOVAL OF A 1.5CM X 5MM PORTION OF RETAINED CATHETER FROM THE PATIENT'S RIGHT CHEST.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL, INC. Implant DOME SUBCUTANEOUS PORT-A-CATH TITANIUM PORT HCA BARD 36 DB 4183

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other