BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 6012779 · Received October 7, 2016

    Report

    Report Number
    1038758-2016-00096
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 9, 2016
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO HAS EVALUATED RETAINED SAMPLES OF THE SAME LOT NUMBER. THE RESULTS ARE ACCEPTABLE WITH NO DEFECTS FOUND DURING TESTING. IN ADDITION, ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND LATEX SCREENING ON ADHESIVES. ASO WILL FOLLOW-UP ON THIS REPORT IF CONSUMER PROVIDES FURTHER INFORMATION. AS OF 10/31/2016 ASO HAS EVALUATED THE UNUSED RETURNED SAMPLE. THE RESULTS ARE ACCEPTABLE WITH NO DEFECTS FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    ASO HAS EVALUATED RETAINED SAMPLES OF THE SAME LOT NUMBER. THE RESULTS ARE ACCEPTABLE WITH NO DEFECTS FOUND DURING TESTING. IN ADDITION, ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND LATEX SCREENING ON ADHESIVES. ASO WILL FOLLOW-UP ON THIS REPORT IF CONSUMER PROVIDES FURTHER INFORMATION.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER USING BANDAGE, IT CAUSED A RASH. CONSUMER STATED THAT BANDAGE WAS TIGHTLY STUCK TO HER SKIN.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER USING BANDAGE, IT CAUSED A RASH. CONSUMER STATED THAT BANDAGE WAS TIGHTLY STUCK TO HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663350 EQUATE ANTIBACTERIAL FLEXIBLE FABRIC XL BANDAGES KGX ASO LLC UPC#681131052931 00047387

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR