BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 6386900 · Received March 8, 2017

    Report

    Report Number
    1219977-2017-00037
    Event Type
    Injury
    Date Received
    March 8, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ON THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: WEIGHT. WE ARE UNABLE TO FULLY INVESTIGATE THIS REPORT AS NO PRODUCT CODE OR LOT NUMBER WAS SUPPLIED. CLINICAL EVALUATION: C-QUR MOSAIC PRODUCTS ARE PROVIDED STERILE AND ARE INTENDED FOR USE IN SOFT TISSUE DEFICIENCIES INCLUDING HERNIA REPAIR, CHEST WALL RECONSTRUCTION, TRAUMATIC OR SURGICAL WOUNDS AND OTHER FASCIAL SURGICAL INTERVENTION PROCEDURES REQUIRING REINFORCEMENT WITH A SUPPORTIVE MATERIAL. RASH IS NOT A SPECIFIC DIAGNOSIS. INSTEAD IT MEANS SKIN INFLAMMATION AND DISCOLORATION THAT CHANGES THE WAY THE SKIN LOOKS. A RASH CAN HAVE MANY CAUSES AND OCCURS IN MANY FORMS. IT USUALLY INVOLVES AN ITCHY RASH ON SWOLLEN, REDDENED SKIN. A RASH IS A COMMON CONDITION THAT'S NOT CONTAGIOUS AND USUALLY ISN'T LIFE-THREATENING. THE INSTRUCTIONS FOR USE (IFU) STATE COMPLICATIONS MAY OCCUR WITH THE USE OF ANY SURGICAL MESH AND INCLUDE, BUT ARE NOT LIMITED TO, INFLAMMATION AND INFECTION. A SKIN REACTION MAY BE DUE TO AN INTRODUCTION OF BACTERIA OR EVEN ENVIRONMENTAL FACTORS.

    Description of Event or Problem · 1

    OVER SIX MONTHS FOLLOWING SURGERY THE PATIENT EXPERIENCED AN ALLERGIC REACTION AROUND THE HERNIA AREA. DOCTOR GAVE HER SOME BENADRYL AND THE RASH SEEMED TO HAVE DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169654 MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention