BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PETROLATUM GAUZE

    MDR report key: 5603382 · Received April 20, 2016

    Report

    Report Number
    MW5061852
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 16, 2016
    Report Date
    April 20, 2016
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED DERMA SCIENCES, INC'S PETROLATUM GAUZE FOR WOUND CARE. I NOTICED THAT THE CONTENTS OF THE BAGS WAS QUITE DRY. I UNDERSTAND THE PURPOSE OF THE PETROLATUM GAUZE IS TO PROVIDE NON-ADHERENT. I RECEIVED ARE DEFECTIVE. I ADDED AQUAPHOR TO THE BANDAGES AFTER MY WOUND STUCK TO THE GAUZE AND CAUSED TREMENDOUS PAIN AND SUBSTANTIAL TIME TO SOAK IN ORDER TO REMOVE THE GAUZE. I NOTIFIED BOTH BYRAM HEALTHCARE AND DERMA SCIENCES. THIS IS AN ISSUE OF QUALITY CONTROL, (LOT: 114549, EXP: 09-2017). A SUPERVISOR AT BYRAM HEALTHCARE ACTUALLY TOOK THE TIME TO GO TO THE WAREHOUSE AND OPENED THE GAUZE WITH THE NOTED LOT NUMBER AND GAUZE FROM AN ADD'L LOT NUMBER AND HE FOUND EVEN MORE WIDESPREAD DRYNESS IN THE GAUZE. I OFFERED TO SEND A SAMPLE OF THE DEFECTIVE PRODUCT TO DERMA SCIENCES, BUT I HAVE NOT HEARD BACK FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246173 PETROLATUM GAUZE PETROLATUM GAUZE FRO DERMA SCIENCES, INC. 114549

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability