BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEAPORT IMPLANTABLE DEVICES

    MDR report key: 950 · Received July 23, 1992

    Report

    Report Number
    950
    Event Type
    Injury
    Date Received
    July 23, 1992
    Date of Event
    March 27, 1992
    Report Date
    May 6, 1992
    Manufacturer
    HARBOR MEDICAL DEVICES, INC.
    Product Code
    LKG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BLOOD CLOTT FORMED IN RIGHT SUBCLAVIN VEIN. THE PATIENT WAS SEEN IN THE PHYSICIANS OFFICE PRIOR TO THE ADMISSION. UNABLE TO DETERMINE THE CAUSE OR EVENTS INVOLVED IN THE USE OF THE DEVICE. SYMPTOMS OF PAIN, AND SWELLING OCCURRED IN RIGHT HAND AND ARM AND AXILLIA PRIOR TO COMING TO THE PHYSICIAN'S OFFICE. ON 5/5/92 PHYSICIAN REVIEW DETERMINED THE DEVICE PROBABLY CAUSED THE THROMBI TO OCCUREDEVICE 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER, INVALID DATA. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEAPORT IMPLANTABLE DEVICES Implant IMPLANTABLE DEVICE LKG HARBOR MEDICAL DEVICES, INC. N/A 552003

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other