BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2006-00057

    MDR report key: 770614 · Received September 25, 2006

    Report

    Report Number
    9614385-2006-00057
    Event Type
    Injury
    Date Received
    September 25, 2006
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION IDENTIFIED A PATCH - SHELL TEAR ON THE POSTERIOR SURFACE THAT MEASURES APPROXIMATELY 30MM WHICH IS LOCATED BETWEEN THE 6 AND THE 9 0'CLOCK POSITIONS (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE TEAR. MICROSCOPIC EXAMINATION (X10) OF THE TEAR CONFIRMED THE TEAR FOLLOWS THE EDGE OF THE BARRIER PATCH, ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MANUFACTURE. A CONCLUSION CAN'T BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FWM

    Patients

    Seq Age Sex Outcome Treatment
    1