BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 15019722 · Received July 14, 2022

    Report

    Report Number
    2184163-2022-00001
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 14, 2022
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECORDS DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED AND THE FINISHED PRODUCT MET ALL QUALITY RELEASE CRITERIA AND SPECIFICATIONS WERE WITHIN ALLOWABLE LIMITS PRIOR TO RELEASE. THE INSPECTION OF SIX UNUSED PADS RECEIVED FROM THE CONSUMER FOUND NO DEFECTS OR ANOMALIES.

    Description of Event or Problem · 0

    THE CONSUMER'S GRANDMOTHER REPORTED THAT THE 15 YEAR OLD CONSUMER HAD BEEN WEARING POISE PADS FOR APPROXIMATELY THREE WEEKS POST BACK SURGERY FOR URINARY INCONTINENCE. ON (B)(6) 2022, AFTER WEARING A PAD ALL DAY WITH NO INCONTINENCE NOTED, SHE EXPERIENCED PAIN AND SWELLING IN HER LABIA AREA. SHE APPLIED ICE PACKS TO THE AFFECTED AREA, WHICH DID NOT REDUCE THE SWELLING. THE FOLLOWING MORNING, SHE WAS ADMITTED TO THE EMERGENCY ROOM WHERE SHE WAS TREATED WITH ORAL AND IV BENADRYL, WHICH WERE INEFFECTIVE IN RELIEVING THE SWELLING. HER LABIA WAS SWOLLEN, BLISTERED AND BUMPY. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 WHERE SHE RECEIVED INTERMITTENT IV FLUIDS, TYLENOL AND IBUPROFEN FOR PAIN, TOPICAL STEROID CREAM FOR SWELLING, AND ADDITIONAL DIAGNOSTIC PROCEDURES. INFECTION AS A CAUSE WAS RULED OUT. SHE WAS DISCHARGED HOME ON (B)(6) 2022 WITH AN UNDETERMINED DIAGNOSIS. IT WAS REPORTED THAT THE CONSUMER'S HEALTH STATUS WAS IMPROVED AT THE TIME OF HOSPITAL DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464418 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY MODERATE LF207627X0440

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Hospitalization