BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 899336 · Received August 1, 2007

    Report

    Report Number
    9614385-2007-00034
    Event Type
    Injury
    Date Received
    August 1, 2007
    Manufacturer
    *
    Product Code
    FWM
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: VISUAL INSPECTION IDENTIFIED A FOLD FLAW THAT MEASURES APPROX 145MM IN TOTAL LENGTH WHICH ENDS IN A SPLIT MEASURING APPROX 11MM IN LENGTH. THE FOLD FLAW STARTS ON THE ANTERIOR SURFACE WHICH CONTINUES OVER THE PERIPHERY AND ONTO THE POSTERIOR SURFACE, WHERE IT DEVELOPS INTO A SPLIT, WHICH IS LOCATED ON THE PERIPHERY OF THE DEVICE, WHICH IS LOCATED ON THE 3 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRODUCT INSPECTION: PRESSURE TESTING IDENTIFIED NO OTHER LEAKS OR BREACHES. MICROSCOPIC EXAMINATION (X10) OF THE BREACH ON THE SHELL IDENTIFIED SIGNS OF FATIGUE ALONG THE SPLIT ON THE FOLD FLAW. THE PRODUCT MET ALL MFG AND QUALITY SPECIFICATIONS POST MFR. CONCLUSION: THE FOLD FLAW / SPLIT ARE NOT MFG FAULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *