BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90102387 DERMACEA GZE SPG 4X4 8PLY STR

    MDR report key: 5367800 · Received January 14, 2016

    Report

    Report Number
    1282497-2016-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Report Date
    December 16, 2015
    Manufacturer
    ALLMED MEDICAL PRODUCTS
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/29/2016. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. ONE BAG OF SAMPLES WAS RETURNED FOR EVALUATION. THE TEXTURE OF THE GAUZE SEEMED A LITTLE LOOSE ON SEVERAL OF THE RETURNED SAMPLES. BASED ON THE INVESTIGATION AND ANALYSIS AT PRESENT, THE CONDITION WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS AND TESTING PROCESS. THE MOST POSSIBLE ROOT CAUSE MAY BE THAT SOME TYPE OF STERILIZATION OCCURRED PRIOR TO USE. AT THIS TIME, THERE IS NO CORRECTIVE/PREVENTIVE ACTION REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 01/14/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER REPORTS THAT THEY ARE EXPERIENCING DIFFICULTY WORKING WITH THE COVIDIEN GAUGE SPONGES. THEY ARE FRAGMENTS AND COMING APART WHEN MANIPULATED. SHREDDING OR FALLING APART ONCE APPLIED TO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26129 90102387 DERMACEA GZE SPG 4X4 8PLY STR GAUZE SPONGE GDY ALLMED MEDICAL PRODUCTS 441001 15006A

    Patients

    Seq Age Sex Outcome Treatment
    1