BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2006-00085

    MDR report key: 809888 · Received January 8, 2007

    Report

    Report Number
    9614385-2006-00085
    Event Type
    Injury
    Date Received
    January 8, 2007
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEFLATION OF UNILATERAL LEFT BREAST IMPLANT, WILL REPLACE BILATERLLY. VISUAL INSPECTION: IDENTIFIED NO DAMAGE. PRESSURE TESTING IDENTIFIED TWO BREACHES MEASURING APPROXIMATELY 1MM IN LENGTH, WHICH ARE LOCATED ON THE ANTERIOR SURFACE APPROXIMATELY 8MM FROM THE VALVE STRAP AT THE 11 O'CLOCK POSITION_(WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). MICROSCOPIC EXAMINATION (X10) OF THE BREACHES IDENTIFIED CELLAR INITIATION POINTS WHICH ARE INDICATIVE OF MECHANICAL TRAUMA. AS NO LOT NO. WAS PROVIDED IT WAS NOT POSSIBLE TO REVIEW THE PRODUCT HISTORY SHEET (MR004) TO CONFIRM IF THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS. CONCLUSION: THE BREACHES ARE NOT MANUFACTURING FAULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1