BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- PRE-SHAPES

    MDR report key: 3082943 · Received April 23, 2013

    Report

    Report Number
    1213643-2013-00167
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 1, 1997
    Report Date
    April 1, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD¿L INFO. THE PATIENT REPORTS THAT THREE YEARS POST IMPLANT HE UNDERWENT SURGICAL REPAIR FOR A RECURRENCE OF HIS HERNIA, HOWEVER, IT IS UNCLEAR WHETHER THE MESH WAS EXCISED AT THIS TIME. THE PATIENT ALLEGES RECURRENCE AND A POSSIBLE INFECTION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. THE WARNING SECTION OF THE IFU STATES ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ ADDITIONALLY, THE PRODUCT WAS MANUFACTURED BY SURGICAL SENSE, PRIOR TO THE DAVOL ACQUISITION OF THE PRODUCT. MFG RECORDS FROM SURGICAL SENSE ARE NOT READILY AVAILABLE FOR REVIEW. THEREFORE, NO DHR WILL BE PERFORMED RELATED TO THIS COMPLAINT. THIS MDR INCLUDES ALL PATIENT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. IF ADD¿L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT: THE PATIENT HAS ALLEGED THAT HE WAS IMPLANTED WITH BARD MESH IN 1994. SOON AFTER THAT THE PATIENT BEGAN EXPERIENCING ABDOMINAL PAIN, PULLING, PROBLEMS, DRAINAGE, PUS FILLED ODOROUS BLISTERS AT INCISION SITE AND PROBLEMS MOVING HIS BOWELS. PATIENT STATES IN 1997, HE HAD A RECURRENCE OF HIS HERNIA WITH SURGICAL REPAIR. PATIENT STATES HIS PROBLEMS HAVE BEEN OFF AND ON FOR 20 YEARS AND THAT HIS PRIMARY CARE PROVIDER HAS ADVISED HIM TO SEE A SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175559 MESH- PRE-SHAPES FTL DAVOL INC., SUB. C.R. BARD, INC. NA 08FE0109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention