BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2007-00007

    MDR report key: 977362 · Received March 2, 2007

    Report

    Report Number
    9614385-2007-00007
    Event Type
    Injury
    Date Received
    March 2, 2007
    Product Code
    FWM
    PMA / PMN Number
    01236780780
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL SURGERY WAS PERFORMED BY DR LEVENTHAL IN 2000 USING HUTCHISON HSH 450 SALINE-FILL IMPLANTS, WHICH WERE FILLED TO AN UNKNOWN VOLUME. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2007. THE IMPLANTS WERE REPLACED WITH UNKNOWN DEVICES. 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 S7735/1 DEMONSTRATED THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATION. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MANUFACTURE. 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