BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIYA HOOK

    MDR report key: 7231 · Received October 14, 1993

    Report

    Report Number
    2024347-1993-09001
    Event Type
    Malfunction
    Date Received
    October 14, 1993
    Report Date
    November 18, 1992
    Manufacturer
    SHERIDAN CATHETER CORPORATION
    Product Code
    FHB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT CUSTOMER COMPLIANED OF HOOK DETACHING AND OF DIFFICULTY RETREIVING IT DURING PROCEDURE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIYA HOOK SAME FHB SHERIDAN CATHETER CORPORATION 154-1080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other