BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL CONVENIENCE KIT

    MDR report key: 6854630 · Received September 11, 2017

    Report

    Report Number
    0001055892-2017-00010
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    July 25, 2017
    Report Date
    November 3, 2017
    Manufacturer
    SYNERGY HEALTH NORTH AMERICA
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DELAYS OR CANCELLATIONS IN PATIENT PROCEDURE WERE REPORTED. THE USER WAS NOT WEARING THE APPROPRIATE GOWN FOR THE PROCEDURE WHEN THE REPORTED EVENT OCCURRED. THE USER WAS WEARING A LEVEL 2 GOWN AND SHOULD HAVE BEEN WEARING A LEVEL 3 OR LEVEL 4 GOWN TO PROVIDE ADEQUATE BARRIER PROTECTION. SYNERGY HEALTH NORTH AMERICA ACCOUNT MANAGER WILL BE CONDUCTING IN-SERVICE TRAINING WITH THE USER FACILITY ON THE PROPER USAGE OF THE GOWNS.

    Additional Manufacturer Narrative · 1

    SYNERGY HEALTH NORTH AMERICA REPRESENTATIVE CONDUCTED CUSTOMER (WAKEMED) IN-SERVICE TRAINING ON OCTOBER 06, 2017 AND OCTOBER 09, 2017 ON THE PROPER USAGE OF SURGICAL GOWNS.

    Additional Manufacturer Narrative · 1

    SYNERGY HEALTH NORTH AMERICA REPRESENTATIVE CONDUCTED CUSTOMER (WAKEMED) IN-SERVICE TRAINING ON OCTOBER 06, 2017 AND OCTOBER 09, 2017 ON THE PROPER USAGE OF SURGICAL GOWNS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AT THE END OF A SURGICAL PROCEDURE AN EMPLOYEE OBSERVED A STRIKE-THROUGH ON THEIR SURGICAL GOWN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE END OF A SURGICAL PROCEDURE AN EMPLOYEE OBSERVED A STRIKE-THROUGH ON THEIR SURGICAL GOWN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AT THE END OF A SURGICAL PROCEDURE AN EMPLOYEE OBSERVED A STRIKETHROUGH ON THEIR SURGICAL GOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634617 SURGICAL CONVENIENCE KIT SURGICAL GOWN LRO SYNERGY HEALTH NORTH AMERICA 1003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other