BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIGIS MEDIUM

    MDR report key: 4315842 · Received December 10, 2014

    Report

    Report Number
    3005619263-2014-00011
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Report Date
    October 30, 2014
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: REVIEWED SAMPLE RETURNED BY CUSTOMER, THERE WAS NO INDICATION THAT A PROPER SEAL WAS MADE INITIALLY. TO INVESTIGATE IF THE FOIL POUCH HAD INSUFFICIENT ADHESIVE, THE POUCH WAS SEALED USING THE BAND SEALER. AFTER SEALING THE POUCH AND INSPECTING THE SEAL ON THE POUCH IT SHOWED NO ISSUES AND COMPLETE SEAL IN THE LOWER AREA. IN CONCLUSION, IT WAS DETERMINED THAT THIS IS A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN OPENED THE OUTER BOX AND PULLED THE FOIL PACKET OUT, THE ENVELOPE FELL THROUGH THE BOTTOM DUE TO THE FOIL NOT BEING SEALED. THE ENVELOPE WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802502 AIGIS MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM3122 14F10466

    Patients

    Seq Age Sex Outcome Treatment
    1