BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M NEXCARE CRACKED HEEL CARE

    MDR report key: 621032 · Received July 11, 2005

    Report

    Report Number
    2110898-2005-00010
    Event Type
    Injury
    Date Received
    July 11, 2005
    Date of Event
    June 3, 2005
    Report Date
    June 3, 2005
    Manufacturer
    3M CONSUMER HEALTH CARE
    Product Code
    NEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO 3M FROM A CUSTOMER THAT THEY HAD USED THE 3M NEXCARE CRACKED HEEL CARE PRODUCT FOR ONE AND A HALF MONTHS WHEN THEY STARTED TO EXPERIENCE PAIN EXTENDING FROM THEIR HEEL TO THEIR KNN AND HIP. THE CUSTOMER REPORTED TO 3M THEY WENT TO THE EMERGENCY ROOM AND THE ER PHYSICIAN SUSPECTED A BONE INFECTION. THE CUSTOMER CONSULTED AN ORTHOPEDIST. A LETTER AND REPORT PROVIDED BY THE CUSTOMER FROM THE CONSULTING ORTHOPEDIST DID NOT REPORT A BONE INFECTION. THE ORTHOPEDIST ORDERED AN MRI IN 2005 AND DID NOTE NONSPECIFIC SIGNS THAT MAY REPRESENT CELLULITIS AND MILD PERONEAL AND POSTERIOR TIBIAL TENOSYNOVITIS. THE ORTHOPEDIST REPORT ALSO STATED THAT THE PATIENT HAD SUED THE 3M PRODUCT BUT DID NOT ATTRIBUTE ANY INJURY TO THE 3M PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M NEXCARE CRACKED HEEL CARE SKIN PROTECTANT NEC 3M CONSUMER HEALTH CARE NA 4246

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention