BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 4731581 · Received April 27, 2015

    Report

    Report Number
    2381757-2015-00019
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    November 1, 2014
    Report Date
    March 29, 2015
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    EYQ
    PMA / PMN Number
    PNONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT IN (B)(6) 2014, SHE PURCHASED AND USED POISE PADS FOR A WEEK. SHE STATED THE PADS CAUSED BLOOD BLISTERS IN THE CREASE BETWEEN HER LEFT LEG AND GENITAL AREA, WHICH BECAME INFECTED, CAUSING A SEVERE ALLERGIC REACTION REQUIRING HOSPITALIZATION, RESULTING IN GANGRENE AND UTI. THE CONSUMER STATED THAT SHE IS ALMOST COMPLETELY HEALED NOW AND IS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275070 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK CORPORATION - CONWAY MILL MODERATE AC432201X1746

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization