BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR, MMT-7002C,10PK GLUCOSE,BSA,17L

    MDR report key: 1912625 · Received November 23, 2010

    Report

    Report Number
    2032227-2010-83250
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    May 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THAT HE HAD A SITE INFECTION SIX MONTHS AGO. THE CUSTOMER STATED THAT HE WAS TREATED BY HIS DOCTOR, AND THEN HE WENT TO THE EMERGENCY ROOM TO BE TREATED. THE CUSTOMER STATED THAT DOES NOT REMEMBER HOW LONG THE SENSOR WAS IN, OR HOW HE PREPARED THE AREA. THE CUSTOMER STATED THAT HE DID SHAVE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR, MMT-7002C,10PK GLUCOSE,BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization