BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3110474 · Received April 26, 2013

    Report

    Report Number
    1213643-2013-00170
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT HAS BEEN ALLEGED THAT THE PATIENT PRESENTED TO DERMATOLOGY WITH A PERSISTENT RED SKIN REACTION NEAR HIS INCISION SITE. ALLEGEDLY THE PATIENT WAS TREATED WITH TOPICAL OINTMENTS AND AFTER NO RESOLVE WAS GIVEN AN ALLERGY TEST WHICH WAS POSITIVE FOR ALLERGY TO TIXOCORTOL-21-PIVALATE AND COBALT DICHLORIDE. TIXOCORTOL-21-PIVALATE IS A TOPICAL ANTI-INFLAMMATORY, CORTICOSTEROID. TYPICAL ALLERGIC REACTIONS INCLUDED REDNESS, SWELLING, AND ITCHING. DERMATOLOGY REQUESTED AND HAS BEEN PROVIDED WITH A PIECE OF FLAT MESH TO PERFORM ALLERGY TESTING. AT THIS TIME THE RESULTS OF THAT TEST HAVE NOT BEEN PROVIDED TO DAVOL. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. THE PATIENT/EVENT INFORMATION THAT WE HAVE BEEN PROVIDED TO DATE IS LIMITED, IF/WHEN ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN REPORTED TO DAVOL VIA MAUDE EVENT REPORT (B)(4). ON (B)(6)2012 - PATIENT WAS IMPLANTED WITH A BARD FLAT MESH DURING AN UNKNOWN PROCEDURE. PATIENT BEGAN TO EXPERIENCE A PERSISTENT RED SKIN REACTION NEAR INCISION SITE AFTER SURGERY. SURGEON WAS UNSURE IF THEY BE CAUSED BY THE DEVICE. PATIENT WAS SEEN BY DERMATOLOGY FOR TREATMENT OF RASH. AT THIS TIME NO SURGICAL INTERVENTION HAS OCCURRED. IF THE ISSUE IS DETERMINED TO BE RELATED TO PATIENT REACTION TO THE DEVICE IT COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182894 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVF0860

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CERAVE CRM| ALLEGRA BID| PER PHYSICIAN'S ASSISTANT - RASH TREATED WITH| ALLEGRA| CEREVE CRM| DESOWEN CRM| THEN CHANGED TO LIDEX