BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18327264 · Received December 14, 2023

    Report

    Report Number
    1417592-2023-00498
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    April 19, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER CONTACT THAT ON (B)(6) 2023 A BANDAGE WAS PLACED OVER A SURGICAL SITE. ON (B)(6) 2023, THE BANDAGE WAS REMOVED AND "WE REALIZED HE HAD A SEVERE REACTION (IT LOOKED LIKE A CHEMICAL BURN) TO THE BANDAGE". IT WAS REPORTED "ON MAY 1, THE DEAD TISSUE AROUND THE WOUND WAS CLEANED OUT AND THE DOCTOR ASSESSED THE AREA WHERE THE REXALL BANDAGE HAD BEEN. THE DOCTOR EXPRESSED THAT, THE WAY THE WOUND LOOKED AT THE EXAM AND HOW IT LOOKED IN THE IMAGES SENT TO HIM ON (B)(6), HE BELIEVED A CHEMICAL REACTION TO THE BANDAGE CAUSED THE WOUND TO OPEN UP". ADDITIONALLY, "WE WERE INSTRUCTED TO CLEAN THE WOUND DAILY WITH WOUND CLEANING SOLUTION AND APPLY SANTYL INTO THE HOLE WHICH WAS NOW WHERE THE INCISION HAD BEEN, AND TO KEEP IT COVERED. USED THE SANTYL FOR A COUPLE OF DAYS, BUT IT APPEARED TO IRRITATE THE WOUND OPENING SOME, SO THE DOCTOR SAID TO SWITCH TO NEOSPORIN INSTEAD. THE WOUND CONTINUED TO REMAIN OPEN, AND THE DOCTOR WANTED TO SEE AGAIN, SO ANOTHER APPOINTMENT WAS SCHEDULED FOR (B)(6) 2023. AGAIN, THE WOUND WAS CLEANED OUT, AND AT THIS APPOINTMENT, WE WERE INSTRUCTED TO DISCONTINUE THE USE OF NEOSPORIN AND TO BEGIN PACKING THE WOUND WITH GAUZE BECAUSE THE WOUND WAS STILL NOT CLOSING. IT TOOK WEEKS FOR THE WOUND TO CLOSE COMPLETELY." A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED TO INCLUDE INVESTIGATION INFORMATION. SAMPLE WAS RECEIVED AND EVALUATED.

    Description of Event or Problem · 0

    "A SEVERE REACTION (IT LOOKED LIKE A CHEMICAL BURN)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326456 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES LP 2201025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other