BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2007-00017

    MDR report key: 844750 · Received April 14, 2007

    Report

    Report Number
    9614385-2007-00017
    Event Type
    Injury
    Date Received
    April 14, 2007
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEFLATION OF THE RIGHT BREAST IMPLANT. BILATERAL EXCHANGE WITH UNK DEVICES. ORIGINAL SURGERY WAS PERFORMED BY DR IN THE YEAR 1999 USING HUTCHISON HSH 500 SALINE-FILL IMPLANTS, WHICH WERE FILLED TO AN UNK VOLUME. THE PT HAS NOT YET UNDER-GONE BILATERAL REPLACEMENT SURGERY, AS THIS IS SCHEDULED FOR 2007. NO PRODUCT WAS RETURNED. AS NO PRODUCT WAS RETURNED IT WAS NOT POSSIBLE TO PERFORM A PRODUCT INSPECTION. REVIEW OF THE PRODUCT HISTORY SHEET FOR LOT NO S5932/1 DEMONSTRATED THAT THE PRODUCT WAS MFG WITHIN SPEC. NO CONCLUSION CAN BE DRAWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1