BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2007-00003

    MDR report key: 820643 · Received January 22, 2007

    Report

    Report Number
    9614385-2007-00003
    Event Type
    Injury
    Date Received
    January 22, 2007
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO PRODUCT WAS RETURNED IT WAS NOT POSSIBLE TO PERFORM A PRODUCT INSPECTION. REVIEW OF THE PRODUCT HISTORY SHEET FOR THE LOT NO S7607/1 DEMONSTRATED THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATION. ORGINAL SURGERY WAS PERFORMED IN 2000. THE LOT NO PROVIDED IN THE CUSTOMER COMPLAINT FORM CONFIRMS THAT THE RIGHT IMPLANT IS A HUTCHISON HSH 500. THE FILL VOLUME OF THE PRODUCT IS UNKNOWN. THE LEFT IMPLANT HAS BEEN IDENTIFIED AS A MENTOR IMPLANT. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON AN UNKNOWN DATE. NO PRODUCT WAS RETURNED. 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