BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOUFFANT CAP, ANNIE BLUE LARGE

    MDR report key: 13028252 · Received December 17, 2021

    Report

    Report Number
    3004763499-2021-00002
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 19, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT FOUND A BROKEN SEWING MACHINE NEEDLE IN HER HAIR WHEN REMOVING THE CAP AFTER AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921825 BOUFFANT CAP, ANNIE BLUE LARGE SURGICAL CAP, SINGLE-USE FYF MOLNLYCKE HEALTH CARE 621815 21276594

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other