BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 5293327 · Received December 14, 2015

    Report

    Report Number
    2184163-2015-00001
    Event Type
    Injury
    Date Received
    December 14, 2015
    Date of Event
    November 14, 2015
    Report Date
    November 17, 2015
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    PNONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CONSUMERS WIFE CALLED AND STATED HER HUSBAND WAS TAKEN TO THE HOSPITAL ON (B)(6), THE DOCTOR DIAGNOSED HIM WITH A UTI, WAS GIVEN IV ANTIBIOTICS. HE IS BETTER NOW AND HOME FROM THE HOSPITAL. CONSUMER HAS BEEN USING THE PRODUCT FOR ALMOST A YEAR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824863 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY LARGE LF516316X1841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR