BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15X20MM BIOMEND

    MDR report key: 1231057 · Received October 28, 2008

    Report

    Report Number
    1121308-2008-00009
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    LYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING SITE REVIEWED THE PRODUCT DEVICE HISTORY RECORDS WITH THE OBJECTIVE OF DETECTING POSSIBLE SCENARIOS FOR A MISSING UNIT. THE REVIEW FOUND THAT OUR DEVICE HISTORY RECORD HAS A STEP BY STEP ACCOUNTABILITY OF LABELS, RAW MATERIALS AND BIOMEND SPONGES. AN EMPTY ENVELOPE WOULD LEAD TO A LEFT-OVER SPONGE WHICH A REVIEW DETERMINED DID NOT OCCUR. AN EMPTY TRAY OR EMPTY BOX WOULD ALSO RESULT IN A LEFT-OVER TRAY/ENVELOPE/SPONGE. PRODUCTION INVOLVES SEVERAL INSPECTION STAGES WITH DIFFERENT PEOPLE INVOLVED. PRODUCT RETAINS WERE INSPECTED AND INDICATED THAT THE PRODUCT MANUFACTURED UNDER THIS LOT MET SPECIFICATION. THERE HAVE BEEN NO REPORTS OF EMPTY PACKAGES IN OTHER COLLAGEN PRODUCTS. BASED ON THE MANUFACTURING AND INSPECTION PROCESS AND LACK OF PRODUCT RETURN FOR EVAL, WE ARE UNABLE TO CONFIRM THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIPT OF THE PACKAGE WITH NO PRODUCT CONTAINED INSIDE. THEY WERE ABLE TO COMPLETE THE OPERATION WITH ADDITIONAL PRODUCT FROM STOCK. THE PT'S CONDITION IS UNK. NO FURTHER INFO HAS BEEN PROVIDED. ADDITIONAL INFO 05/15/2008: DURING AN INTERNAL AUDIT, IT WAS ADVISED THAT THE INFO RECEIVED PERTAINING TO THIS EVENT WAS NOT CONCLUSIVE AND THEREFORE DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15X20MM BIOMEND NONE LYC INTEGRA LIFESCIENCES 1060868

    Patients

    Seq Age Sex Outcome Treatment
    1