BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAPLUS SHOE COVER EXTRA TRACTION XLG 80

    MDR report key: 7141510 · Received December 22, 2017

    Report

    Report Number
    3011270181-2017-00010
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    January 16, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    LYU
    UDI-DI
    30680651691959
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE OR LOT NUMBER WAS NOT RECEIVED FOR THE AFFECTED PRODUCT; HOWEVER, BASED ON THE MANUFACTURING HISTORY, THERE IS NO LOT NUMBER CA716004 AS REPORTED THAT WAS PRODUCED FOR PRODUCT 69195, THE DEVICE HISTORY RECORDS CAN NOT BE TRACED FOR THIS LOT NUMBER. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 24JAN2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER WHO STATED, "THERE HAS BEEN A MAJOR EMPLOYEE INJURY HERE AT THE HOSPITAL WITHIN THE LAST FEW DAYS." THE WAS NO TRACTION AT THE BOTTOM OF THE SHOW COVER AND THE EMPLOYEE SLIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922183 NOVAPLUS SHOE COVER EXTRA TRACTION XLG 80 X-TRA TRACTION* SHOE COVER, XL, BLUE LYU HALYARD HEALTH 69195 CA716004 30680651691959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other