BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 15736940 · Received November 4, 2022

    Report

    Report Number
    1038758-2022-00046
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 7, 2022
    Report Date
    November 4, 2022
    Manufacturer
    ASO AMERICAS, S. DE R. L. DE C. V.
    Product Code
    LRR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2022 ASO SUBMITTED RETAINED SAMPLES FOR TESTING WITH NO DEFECTS OR OBSERVATIONS. ASO REVIEWED RECORDS OF SATISFACTORY BIOCOMPATIBILITY TESTS FOR ALL ADHESIVE BANDAGES ADDED TO THE FIRST AID KIT WITH NO ISSUES NOTED. IN ADDITION, COMPLAINT DATABASE WAS REVIEWED AND NO NEGATIVE TREND HAS BEEN IDENTIFIED FOR THE ASSOCIATED PRODUCT. REFER TO THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    CONSUMER STATED ON (B)(6) 2022 THAT PRODUCT CAUSED BLISTERS. CONSUMER STATED THAT HE SOUGHT MEDICAL ATTENTION. CONSUMER STATED THAT HOSPITAL INFORMED THAT CONSUMER WAS HAVING A SEVERE LATEX ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335193 EQUATE ALL-PURPOSE FIRST AID KIT WITH ANTIBACTERIAL BANDAGES LRR ASO AMERICAS, S. DE R. L. DE C. V. UPC#681131228312 00164295

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other