BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8864050 · Received August 6, 2019

    Report

    Report Number
    2184163-2019-00006
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 6, 2019
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY IS CONDUCTING A REVIEW OF THE DHR (DEVICE HISTORY RECORD) AND SUPPORTING QUALITY RECORDS.

    Description of Event or Problem · 1

    CONSUMER REPORTED SHE DEVELOPED A SKIN IRRITATION AND A CYST WHILE USING THE PADS. SHE RECEIVED MEDICAL TREATMENT AT THE DOCTOR AND POWDER WAS PUT ON TO ALLEVIATE THE IRRITATION. THE CYST WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660206 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY ULTIMATE LONG LF828721X1102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention