BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEAL TIGHT CAST AND BANDAGE PROTECTOR

    MDR report key: 6809659 · Received August 22, 2017

    Report

    Report Number
    MW5071722
    Event Type
    Injury
    Date Received
    August 22, 2017
    Manufacturer
    UNK
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED AN ARM PROTECTOR TO BATHE AFTER ELBOW SURGERY (B)(6)2017. BATHED LATE (B)(6)2017 AFTER USING ARM PROTECTOR. BATHED AGAIN USING ARM PROTECTOR AND ABOUT AN HOUR LATER, NOTICED LARGE HIVES ON MY SURGERY ARM AT THE BICEP AREA. THE HIVES AND ITCHING WORSENED AND HIVES SURROUNDED MY UPPER BICEP INCLUDING THE UNDER ARM AREA. WENT TO THE ER AT (B)(6) HERE AND IT WAS DETERMINED TO BE A TOPICAL DERMATITIS. WAS GIVEN SCRIPT FOR PREDNISONE PACK AND ANTIHISTAMINE. EARLY THIS AM STILL HAD HIVES AND WAS REVIEWING ALL THAT WAS NEW THAT MIGHT BE IMPLICATED IN THIS. REALIZED I HAD USED AN ARM PROTECTOR (OTC) AND LOOKED AT THE DEVICE'S INFO ON THE DEVICE. I AM HIGHLY REACTIVE TO LATEX BUT THERE WAS NOTHING ON THE PRINTED INFO NOR ON THE INFO ONLINE TO SUGGEST LATEX. THE PRODUCT IS MADE IN (B)(4). "SEAL-TIGHT CAST AND BANDAGE PROTECTOR." THIS IS MY THIRD ARM SURGERY AND HAVE USED THE PRODUCT LAST ABOUT 2 YEARS AGO. THIS WAS A NEW PURCHASE AND HAD NEVER HAD A PROBLEM PRIOR. THE HIVES HAVE LESSENED BUT NOT TOTALLY ABATED. "IS THIS INFO USED TO YOU - THEY ADVERTISE PRODUCTS FOR KIDS THROUGH ADULTS, WHICH CONCERNS ME. AND WHAT ELSE CAN I DO?" THANK YOU IN ADVANCE FOR YOUR ATTENTION IN THIS MATTER. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589858 SEAL TIGHT CAST AND BANDAGE PROTECTOR COVER, CAST KIA UNK ARM PROTECTOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention