BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREEN BY ACE SELF ADHERING ELASTIC BAND

    MDR report key: 3190114 · Received June 21, 2013

    Report

    Report Number
    2110898-2013-00033
    Event Type
    Other
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 20, 2013
    Manufacturer
    3M CARIBE
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CUSTOMER USED (B)(6) BY (B)(6) SELF ADHERING ELASTIC BANDAGE ON HER FOOT FOR SUPPORT, TO BRACE THE FOOT. WRAPPED IT DIRECTLY ON SKIN AROUND BACK OF HEEL AND UP AND AROUND NEAR ANKLE. ON (B)(6) (THIRD USE) WRAPPED IT AGAIN, BUT WHEN SHE REMOVED IT NOTICED HER FOOT WAS ITCHY. TODAY, (B)(6) HER FOOT IS "ALL BLOWN UP AND ITCHING", "ALL RED, BUMPY AND BLOTCHY ON TOP OF FOOT." SHE HAS NOT YET SEEN A DOCTOR ABOUT HER FOOT. SHE IS NOT AWARE OF ANY ALLERGIES. A COPY FROM THE DOCTOR ON DIAGNOSIS, THE BILL AND PRESCRIPTION SHE WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283579 WALGREEN BY ACE SELF ADHERING ELASTIC BAND 880.5075 ELASTIC BANDAGE FQM 3M CARIBE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other