BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED ANTI-BACTERIAL STRONG STRIPS, XL, LATEX FREE

    MDR report key: 3664705 · Received March 4, 2014

    Report

    Report Number
    MW5034810
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 4, 2014
    Manufacturer
    RITE-AID
    Product Code
    MXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LAST WEEK, PT HAD A NEEDLE PUNCTURE ON HER LEFT THUMB. THE ABOVE MENTIONED BAND AID WAS APPLIED TO IT. THE NEXT MORNING, WHILE TRYING TO PULL IT OUT, IT CAME OFF WITH HER SKIN. SHE STARTED BLEEDING AND WAS RUSHED TO THE ER, WHERE IT WAS DETERMINED THAT SHE WAS HAVING AN ALLERGIC REACTION. SHE CALLED (B)(6) AND ASKED FOR THE ACTIVE INGREDIENTS IN THE DEVICE AND WAS TOLD IT WAS BENZALKONIUM CHLORIDE 0.1% BUT THAT SHE SHOULD NOTE THAT THE PROBLEM WASN'T THE ACTIVE INGREDIENT BUT THE ADHESIVE ON THE STRIP. THE WOUND IS NOW HEALING BUT IS GOING TO LEAVE A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130427 ADVANCED ANTI-BACTERIAL STRONG STRIPS, XL, LATEX FREE BAND-AID MXE RITE-AID

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR