BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3D MAX MESH

    MDR report key: 2508485 · Received March 20, 2012

    Report

    Report Number
    1213643-2012-00197
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    September 6, 2011
    Report Date
    February 13, 2015
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K081010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. THE PT REPORTED HE HAS RETAINED COUNCIL AND WILL NOT BE PROVIDING ANY FURTHER INFO. BASED ON THE INFO PROVIDED IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT REPORTS THE 3D MAX MESH USED ON THE RIGHT SIDE AND WAS FOUND ON THE RIGHT MIDLINE ON TOP OF THE BLADDER. THE PT REPORTS A VARIETY OF COMPLICATIONS HOWEVER MEDICAL RECORDS HAVE NOT BEEN PROVIDED. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED, THEREFORE, A MFG REVIEW IS NOT POSSIBLE. ADDITIONALLY, IT IS NOT REPORTED THE MESH USED ON THE RIGHT SIDE WAS EXPLANTED AND NO SAMPLE WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. SEE MDR 1213643-2012-000196 FOR INFO RELATED TO THE 3D MAX MESH USED ON THE LEFT SIDE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PT: THE PT ALLEGED, ON (B)(6) 2009 HE UNDERWENT BILATERAL HERNIA SURGERY WITH BARD 3D MAX MESH. FROM THE TIME OF IMPLANT, THE PT REPORTED HE EXPERIENCED TESTICULAR PAIN, AND SWELLING. THE PT WAS SEEN BY A UROLOGIST WHO SAID THERE WAS A PROBLEM WITH THE MESH. ON NI/NI/NI, THE PT UNDERWENT MESH EXPLANT ON THE LEFT INGUINAL SIDE. ON NI/NI/2011, THE PT HAD A SUPRAPUBIC CATHETER PLACED, THE PT REPORTED THE MD TOLD HIM THEY FOUND THE MESH IN THE MIDLINE, RIGHT ON TOP OF THE BLADDER. THE PT ALLEGED MESH MIGRATION (FOR THE RIGHT SIDED MESH). THE PT REPORTS HE IS STILL UNABLE TO PASS URINE, CAN NOT HAVE SEX, AND IS COMPLETELY DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D MAX MESH FTL DAVOL INC. NA HUSH0641

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R| S