BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR, MMT-7002E, 1PK, GLUCOSE, BSA, 17L

    MDR report key: 1841118 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82658
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SKIN IRRITATION AND PAIN AT THE SITE WHERE THE SENSOR WAS INSERTED. THE CUSTOMER WENT TO HIS HEALTHCARE PROFESSIONAL FOR TREATMENT, AND WAS TOLD TO RETURN IF THE ISSUE CONTINUED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR, MMT-7002E, 1PK, GLUCOSE, BSA, 17L GLUCOSE SENSOR MDS MEDTRONIC MINIMED MMT-7002E

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization