BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AAMI LEVEL 3 TOGA X-LARGE

    MDR report key: 7772054 · Received August 10, 2018

    Report

    Report Number
    0001526350-2018-00766
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 18, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FYA
    PMA / PMN Number
    PK132386
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) FOR THE AAMI LEVEL 3 TOGA X-LARGE, PART NUMBER 00990031210 AND LOT NUMBER D180503, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2018, IT WAS REPORTED FROM CYPRESS POINTE THAT FIVE AAMI LEVEL 3 TOGAS X-LARGE BLED THROUGH AND WERE CONTAMINATED WITH BODILY FLUID. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS NOT BEING RETURNED TO ZIMMER BIOMET. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    TOGA GOWNS BLED THRU AND WERE CONTAMINATED WITH BODILY FLUID. NO ADVERSE EVENTS WERE REPORTED AS A PART OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612741 AAMI LEVEL 3 TOGA X-LARGE GOWN, SURGICAL FYA ZIMMER SURGICAL, INC. D180503

    Patients

    Seq Age Sex Outcome Treatment
    1