BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 6376449 · Received March 3, 2017

    Report

    Report Number
    1038758-2017-00007
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 3, 2017
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2017 ASO HAS NOTIFIED THE MANUFACTURER ABOUT THE EVENT. THE MANUFACTURER EVALUATED RETAINED SAMPLES OF THE SAME LOT NUMBER. REFER TO SECTION FOR FURTHER DETAILS. THE MANUFACTURER IS STILL REVIEWING THE BATCH RECORDS AND WILL UPDATE ASO WITH FINAL INVESTIGATION. ASO WILL FOLLOW-UP ON THIS REPORT AS SOON AS WE RECEIVE FURTHER INFORMATION FROM THE MANUFACTURER. ON (B)(6) 2017 ASO RECEIVED COMPLETED INVESTIGATION FROM THE MANUFACTURER. REFER TO SECTION FOR FURTHER DETAILS. SECTION CODE "CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS" REMOVED.

    Additional Manufacturer Narrative · 1

    AS OF 02/27/2017 ASO HAS NOTIFIED THE MANUFACTURER ABOUT THE EVENT. THE MANUFACTURER EVALUATED RETAINED SAMPLES OF THE SAME LOT NUMBER. THE MANUFACTURER IS STILL REVIEWING THE BATCH RECORDS AND WILL UPDATE ASO WITH FINAL INVESTIGATION. ASO WILL FOLLOW-UP ON THIS REPORT AS SOON AS WE RECEIVE FURTHER INFORMATION FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    CONSUMER'S DAUGHTER (CARE PROVIDER AND REGISTERED NURSE) REPORTED THAT AFTER 8 DAYS WEARING THE DRESSING HER MOTHER'S SKIN STARTED TO HAVE AN ODOR. CONSUMER STATED THAT PRODUCT WAS NOT PEELING OFF THE EDGES AND WHEN REMOVING THE BANDAGE THIS PULLED THE SKIN OFF FROM HER LEG.

    Description of Event or Problem · 1

    CONSUMER'S DAUGHTER (CARE PROVIDER AND REGISTERED NURSE) REPORTED THAT AFTER 8 DAYS WEARING THE DRESSING HER MOTHER'S SKIN STARTED TO HAVE AN ODOR. CONSUMER STATED THAT PRODUCT WAS NOT PEELING OFF THE EDGES AND WHEN REMOVING THE BANDAGE THIS PULLED THE SKIN OFF FROM HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160105 CVS HEALTH ADVANCED HEALING HYDROCOLLOID ADHESIVE PADS NAD EUROMED, INC. UPC#050428397930 00042130

    Patients

    Seq Age Sex Outcome Treatment
    1