BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHARMA-GLOVE

    MDR report key: 12318358 · Received August 12, 2021

    Report

    Report Number
    MW5103224
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    August 11, 2021
    Report Date
    August 11, 2021
    Product Code
    IWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMA-GLOVES - STERILE GLOVES NOT SEALED, PACKAGED INCORRECTLY (E.G. THUMBS ON WRONG SIDE, UPSIDE DOWN, LEFT WHERE RIGHT SHOULD BE OR VICE VERSA. THE LOT NUMBER IS N78/FKTPM 9600001-9. BATCH: N780520, MFG 9-2020. EXP DATE 9- 2025. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212285 PHARMA-GLOVE RADIOGRAPHIC PROTECTIVE GLOVE IWP N78/FKTPM 9600001-9

    Patients

    Seq Age Sex Outcome Treatment
    1