BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ADV AB W/P ADH PAD 3X4 6CT

    MDR report key: 20190318 · Received September 11, 2024

    Report

    Report Number
    1417592-2024-00846
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2024 THE USER EXPERIENCED A "CHEMICAL BURN" ON THEIR LEFT LATERAL TORSO WHERE THE BANDAGE WAS APPLIED. PER THE CUSTOMER THE BANDAGE WAS ON FOR "A COUPLE OF HOURS" AND THE CHILD "STARTED SCREAMING IN PAIN". PER THE CUSTOMER THE CHILD WAS TAKEN TO THE DOCTOR'S OFFICE ON (B)(6) 2024 WHERE THE DOCTOR STATED THE INJURY WAS "OBVIOUSLY A CHEMICAL BURN" AND PROVIDED THE CUSTOMER WITH "SILVER SULFADIAZINE CREAM 1% AND (B)(6) HEALING OINTMENT". PER THE CUSTOMER AS OF TODAY (TUESDAY (B)(6) 2024) THE AREA "IS STILL NOT COMPLETELY HEALED". THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THE REPORTED INCIDENT. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2024 THE USER EXPERIENCED A "CHEMICAL BURN" ON THEIR LEFT LATERAL TORSO WHERE THE BANDAGE WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539084 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other