BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DRAINABLE POUCH W/FILTER

    MDR report key: 3879463 · Received May 29, 2014

    Report

    Report Number
    1000317571-2014-00032
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    EZQ
    PMA / PMN Number
    K780454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. IT WAS NOTED THAT THE PRODUCT WAS IN USE FOR TWO DAYS. IT WAS FURTHER REPORTED END USER CHANGES APPLIANCE EVERY TWO OR THREE DAYS. ALTERNATE PRODUCT APPLIANCES SENT. END USER WAS ENCOURAGED END TO REVIEW CURRENT MEDICATIONS WITH HER HEALTH CARE PROVIDERS INCLUDING PHARMACIST. THE END USER WENT ON TO REPORT SHE SAW HER PRIMARY PHYSICIAN WHO PRESCRIBED A PILL AND CREAM WHICH DID NOT HELP. NO INFORMATION WAS PROVIDED ON THE NAMES OF THE PILL AND CREAM PRESCRIBED. SHE INFORMED OF BEING PRESCRIBED A PENICILLIN MEDICATION WHICH SHE DECLINED TO TAKE DUE TO PENICILLIN ALLERGY. SHE REPORTS SHE FOLLOWED WITH SURGEON WHO DID NOT RECOMMEND ANY INTERVENTIONS. SHE WENT ON TO REPORT THAT SHE WILL SEE THE DERMATOLOGIST (B)(6) 2014. A QUALITY INVESTIGATION WAS PERFORMED ON (B)(4) 2014. THE PRODUCT LOT NUMBER WAS RECORDED AS CNO (COULD NOT OBTAIN) INDICATING NO LOT NUMBER WAS AVAILABLE. AS NO COMPLAINT SAMPLE WAS RECEIVED, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. NO EVIDENCE WAS FOUND THAT PRODUCT FAILED TO MEET ALL OF THE REQUIREMENTS AND SPECIFICATIONS AT THE TIME OF MANUFACTURE. THERE ARE NO ADDITIONAL COMPLAINTS REPORTED FOR THIS SPECIFIC ICC CODE. A REVIEW OF THE COMPLAINT LISTING FOR THE PREVIOUS 12 MONTHS FOR THIS PRODUCT ICC CODE INDICATES THAT THIS WAS THE ONLY COMPLAINT REGISTERED FOR THIS ICC CODE, DATE AND COMPLAINT ISSUE. THE EVALUATION WAS CONDUCTED AND NO CORRECTIVE ACTIONS WILL BE RAISED AS PER SOP 535. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    END USER REPORTS SHE DEVELOPED A RASH TO BUTTOCKS, WHICH THEN SPREAD TO ARMS LEGS TORSO AND UNDER MASS AND TAPE COLLAR OF HER OSTOMY APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316905 SUR-FIT NATURA 2 PC DRAINABLE POUCH W/FILTER POUCH, COLOSTOMY EZQ CONVATEC LIMITED 411266 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention