BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER PRO PLUS

    MDR report key: 8590804 · Received May 8, 2019

    Report

    Report Number
    8590804
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    February 27, 2019
    Report Date
    April 9, 2019
    Manufacturer
    SVS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLINICAL AREA REPORTED THAT PREMIER PRO PLUS NON STERILE GLOVE SIZE MEDIUM (5063) HAVE FINE GLITTER ON THEM THAT RUBS OFF WHEN TOUCHED. LOT NUMBER: CEH-10-06, MANUFACTURED: 2018-10. OUR SYSTEM-WIDE MATERIALS MANAGEMENT CHECKED MULTIPLE BOXES W/ THIS LOT # AND ALL HAD THE FINE GLITTER. THE FOLLOWING ACTION WAS TAKEN WITHIN OUR SYSTEM: BASED ON OUR CURRENT STOCK, WE HAVE ESTIMATED THAT (B)(4) BOXES OF THIS LOT NUMBER HAVE BEEN DISTRIBUTED THROUGHOUT OUR HOSPITAL SYSTEM. WE IDENTIFIED POTENTIALLY 79 DIFFERENT LOCATIONS OUTSIDE THE SUPPLY WHO COULD HAVE THESE GLOVES. NOTIFICATIONS WERE SENT TO THE OTHER LOCATIONS FOR THESE TO BE PULLED AND RETURNED TO THE MAIN WAREHOUSE WE PROVIDED A LIMITED SUBSTITUTE FOR THIS GLOVE WITH ANOTHER PRODUCT AND ORDERED (B)(4) OF THE PREMIER GLOVE (DIFFERENT LOT #) TO BE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384401 PREMIER PRO PLUS POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE LZA SVS LLC 5063 CEH 10-06

    Patients

    Seq Age Sex Outcome Treatment
    1