BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1PC-1PC DRAINABLE POUCH W. STOMAHESIVE

    MDR report key: 4121364 · Received September 19, 2014

    Report

    Report Number
    9618003-2014-10218
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    September 14, 2011
    Manufacturer
    HAINA
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER COULD NOT BE OBTAINED. A REVIEW OF THE BATCH RECORD AND RETAIN EVALUATION COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. A REVIEW OF COMPLAINT TREND FOR PREVIOUS 12 MONTHS WAS PERFORMED AND THERE ARE TOTAL OF (B)(4) COMPLAINTS OF THIS TYPE FOR THIS ICC CODE. THERE IS NO OBJECTIVE EVIDENCE OF NONCONFORMITY.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATES THAT PATIENT STATES, SHE DEVELOPED A RED SPOTTY RASH TO SKIN UNDER STOMAHESIVE PORTION OF SKIN BARRIER 1 WEEK PRIOR TO COMPLAINT RECEIPT. APPLIANCE CHANGE PROCEDURE AND CRUSTING TECHNIQUE WAS REVIEWED WITH PATIENT. RECOMMEND TO CLEAN WITH WATER ONLY AND NOT TO USE ANY PRODUCTS UNDER SKIN BARRIER. SAMPLES SENT AND PATIENT WAS ADVISED TO CALL CVT OR FOLLOW WITH HCP IF NO IMPROVEMENT. PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583505 ACTIVELIFE 1PC-1PC DRAINABLE POUCH W. STOMAHESIVE POUCH, COLOSTOMY EZQ HAINA 022771 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention