BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3D MAX MESH

    MDR report key: 3011018 · Received March 11, 2013

    Report

    Report Number
    1213643-2013-00087
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 4, 2012
    Report Date
    February 15, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K081010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS A PT WITH A HISTORY OF INGUINAL HERNIAS WHO IS AN AVID WEIGHT LIFTER WHICH ACCORDING TO HIS MD "COMPLICATES THE PICTURE" AS HE CONTINUES TO LIFT TREMENDOUS AMOUNTS OF WEIGHT WHILE EXPERIENCING GROIN PAIN. THE MEDICAL RECORDS PROVIDED DO NOT COVER THE PERIOD BEYOND THE 2010 OFFICE VISITS; THEREFORE THE PTS' CLINICAL COURSE BEYOND THAT TIME IS UNCLEAR. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE F/U 1 MDR 1213643-2013-00038 FOR INFO RELATED TO THE OTHER 3DMAX MESH IMPLANTED ON (B)(6) 2009.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED INFECTION, ADDITIONAL SURGERY, PAIN DEFECTIVE MESH, EXPLANT. THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2009 - LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIAS. TWO 3DMAX MESH WERE USED FOR THIS REPAIR. ON (B)(6) 2010 - OFFICE VISIT: PT PRESENTED WITH PERSISTENT PAIN AND PULLING SENSATION IN THE RIGHT GROIN AREA OF THE PRIOR HERNIA REPAIR. NO RECURRENCE NOTED. ON (B)(6) 2010 - OFFICE VISIT: PT PRESENTED WITH INCAPACITATING BILATERAL GROIN PAIN SINCE HERNIA REPAIR. COMPLICATING THE PICTURE IS THAT THE PT IS AN AVID WEIGHT LIFTER AND LIFTS A TREMENDOUS AMOUNT OF WEIGHT AND IS STILL DOING THIS. HIS TREATMENT TO DATE HAS CONSISTED OF VISITS TO THE PAIN CLINIC PRIMARILY FOR MEDICATION. THE ATTORNEY REPORT ALLEGES THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AND HAD SURGERY IN RELATION TO THE MESH THAT HAD BEEN PLACED IN 2009. NO MEDICAL RECORDS/LAB RESULTS HAVE BEEN PROVIDED FOR THIS SURGERY. IT IS UNCLEAR IF ONE OR BOTH OF THE MESH WERE EXCISED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102620 3D MAX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTF0623

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention PAIN CLINIC VISITS