BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 14025073 · Received April 6, 2022

    Report

    Report Number
    3015967359-2022-00613
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    February 9, 2021
    Report Date
    January 10, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    FSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DISCARDED BY USER.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. H3 OTHER TEXT : NO PRODUCT RETURN.

    Description of Event or Problem · 0

    PER THE CUSTOMER THE PATIENT WAS EXPERIENCING PAIN AFTER A MASTECTOMY. THE PATIENT UNDERWENT ADDITIONAL SURGERY AND A PIECE OF THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

    Description of Event or Problem · 0

    PER THE CUSTOMER THE PATIENT WAS EXPERIENCING PAIN AFTER A MASTECTOMY. THE PATIENT UNDERWENT ADDITIONAL SURGERY AND A PIECE OF THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064748 UNKNOWN_INSTRUMENTS_PRODUCT LIGHT, SURGICAL, FIBEROPTIC FSZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    2201195 UNKNOWN_INSTRUMENTS_PRODUCT LIGHT, SURGICAL, FIBEROPTIC FSZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other