BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHON CATHETER

    MDR report key: 3374 · Received July 22, 1992

    Report

    Report Number
    3374
    Event Type
    Injury
    Date Received
    July 22, 1992
    Date of Event
    May 11, 1992
    Report Date
    May 22, 1992
    Manufacturer
    CATH TEC
    Product Code
    LKG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    GROSHONG CATHETER WAS PLACED JANUARY 18, 1989. PATIENT HAS PROVIDED HER OWN CARE SINCE THAT TIME. THERE WAS NO SPECIFIC EVENT PRIOR TO THE FRACTURE OF THE CATHETER. PATIENT NOTED THAT "IT FELT DIFFERENT" AND INVESTIGATION BY THE PATIENT'S PHYSICIAN REVEALED THAT A 6 INCH PIECE OF THE CATHETER HAD BROKER OFFINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHON CATHETER Implant INFORMATION NOT AVAILABLE LKG CATH TEC NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention