BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M COMPLY LEAD FREE INDICATOR TAPE

    MDR report key: 4381343 · Received December 29, 2014

    Report

    Report Number
    2110898-2014-00088
    Event Type
    Injury
    Date Received
    December 29, 2014
    Date of Event
    November 3, 2014
    Report Date
    December 5, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    JOJ
    PMA / PMN Number
    K101528
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO CODE COULD BE IDENTIFIED. THE EVALUATION HAS NOT BEEN CONDUCTED AS OF THE DATE OF THIS REPORT AND IS PENDING. CONCLUSION NOT YET AVAILABLE- EVALUATION IN PROCESS . THE DEVICE IS UNDERGOING AN EVALUATION BUT HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION OF THE RETURNED PRODUCT IS COMPLETED. THE ACTUAL PRODUCT USED WAS RECEIVED ON 12/23/2014. END OF REPORT.

    Description of Event or Problem · 1

    A FEMALE EMPLOYEE IN THE HOSPITAL STERILE PROCESSING DEPARTMENT USED AN INDICATOR TAPE. ABOUT 6 WEEKS AGO THE CUSTOMER ALLEGED REDNESS, BURNING AND IRRITATION ON HER HANDS, PRIMARILY ON THE FINGERS. THE ALLEGED SKIN IRRITATION WAS WORSE ON THE RIGHT HAND; THE CUSTOMER IS RIGHT-HANDED. SHE REPORTED THAT THE SKIN IRRITATION WOULD RESOLVE OVER THE WEEKEND WHEN SHE WAS NOT AT WORK, AND WOULD RECUR WHEN SHE RETURNED TO WORK. THE CUSTOMER WAS GIVEN A PRESCRIPTION HYDROCORTISONE WHICH HAS HELPED WITH THE SKIN IRRITATION. SHE IS NOW WEARING GLOVES AND THE SKIN IRRITATION HAS NOT RETURNED. THE CUSTOMER HAS NO HISTORY OF SKIN SENSITIVITIES OR LATEX ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855407 3M COMPLY LEAD FREE INDICATOR TAPE STERILIZATION PROCESS INDICATOR JOJ 3M HEALTH CARE 2015-12 RY

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other NONE SPECIFIED.