BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 12301140 · Received August 10, 2021

    Report

    Report Number
    12301140
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 23, 2021
    Report Date
    July 29, 2021
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NARRATIVE FROM STAFF: THE BLUE MEDICHOICE PC3.5 NITRILE GLOVES ARE HIGHLY DEGRADABLE. THERE HAVE BEEN SEVERAL OCCURRENCES ALONG WITH OTHER PEERS. THEY TEAR AND DEGRADE WHEN CLEANING WITH OUR FACILITY/EQUIPMENT APPROVED CLEANERS. THEY ALSO OFTEN BREAK WHEN DONNING/DOFFING. THIS IS A HYGIENE ISSUE. MANUFACTURER RESPONSE FOR PATIENT EXAMINATION GLOVE, SPECIALTY, MEDICHOICE (PER SITE REPORTER): REPRESENTATIVE FOR OWENS AND MINOR HAS THE GLOVES AND IS INVESTIGATING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201406 MEDICHOICE PATIENT EXAMINATION GLOVE, SPECIALTY LZC OWENS & MINOR DISTRIBUTION, INC. GLV9201 2101ABN31AA

    Patients

    Seq Age Sex Outcome Treatment
    1