BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M FLUID RESISTANT FACE MASK

    MDR report key: 111581 · Received August 6, 1997

    Report

    Report Number
    2110898-1997-00022
    Event Type
    Injury
    Date Received
    August 6, 1997
    Date of Event
    November 22, 1996
    Report Date
    August 4, 1997
    Manufacturer
    3M MEDICAL PLANT
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 22, 1996, THE PT WAS REMOVING THE SUBJECT DEVICE WHEN IT SLIPPED FROM HER HAND, STRIKING HER EYE. THE PT CONSULTED A MEDICAL DR IMMEDIATELY AND WAS ADVISED TO COVER HER EYES AND REST FOR 24 HRS. THE FOLLOWING DAY, HER EYES HAD NOT IMPROVED, AND THE MEDICAL DR ADVISED FURTHER REST. ON THE THIRD DAY POST INJURY, THE PT CONSULTED ANOTHER DR WHO DIAGNOSED BILATERAL EPITHELIAL CORNEAL ABRASIONS. BY THIS TIME, THE PT'S EYES WERE STARTING TO REPAIR. IN JANUARY OF 1997, AFTER CAMPING AND BEING IN DRY CONDITIONS FOR TWO WEEKS, THE PT HAD RECURRING SYMPTOMS IN THE RIGHT EYE. THE PT CONSULTED AN OPTHAMOLOGIST WHO INDICATED THAT THERE WAS AN AREA OF LOOSE CORNEAL EPITHELIUM ON THE RIGHT EYE, AND THE LEFT CORNEA WAS NORMAL. ACCORDING TO THE OPTHAMOLOGIST, THE PT HAD A HISTORY AND SIGNS TYPICAL OF THE CONDITION KNOWN AS RECURRENT CORNEAL ABRASION AS A RESULT OF THE NOVEMBER 22 INCIDENT. ON MARCH 6, 1997, THE OPTHAMOLOGIST'S OPINION WAS THAT THE SYMPTOMS IN THE RIGHT EYE HAVE IMPROVED WITH CONTINUED USE OF OCULAR LUBRICANT FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M FLUID RESISTANT FACE MASK SURGICAL MASK FXX 3M MEDICAL PLANT 1942FB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention