BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 1914994 · Received November 30, 2010

    Report

    Report Number
    1213643-2010-00515
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    January 11, 2010
    Report Date
    November 1, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR AN INFECTION. 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." AS THE MESH WAS IMPLANTED 4 YEARS BEFORE THE INFECTION DEVELOPED/WAS DIAGNOSED, THE MESH MOST LIKELY DID NOT CAUSE THE INFECTION. HOWEVER, AS NO PRODUCT HAS BEEN RETURNED FOR EVALUATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2010-00207 FOR INFORMATION RELATED TO THE VENTRALEX MESH IMPLANTED ON (B)(6) 2004. SEE MDR 1213643-2010-00517 FOR INFORMATION RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2005. SEE MDR 1213643-2010-00514 FOR INFORMATION RELATED TO THE OTHER VENTRALEX MESH IMPLANTED ON (B)(6) 2005. SEE MDR 1213643-2010-00516 FOR INFORMATION RELATED TO THE VENTRALEX MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PATIENT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF DEFECTIVE PRODUCT, A BARD VENTRALEX & COMPOSIX KUGEL PATCHES. SPECIFICALLY, AS A RESULT OF HAVING THE BARD VENTRALEX MESH AND COMPOSIX KUGEL PATCHES IMPLANTED, PATIENT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION. INFORMATION FROM MEDICAL RECORDS RECEIVED FOR REVIEW: ON (B)(6) 2004 - REPAIR OF INCISIONAL HERNIA WITH VENTRALEX MESH. ON (B)(6) 2005 - REPAIR OF INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH. ON (B)(6) 2005 - REPAIR OF 2 INCISIONAL HERNIAS WITH 2 VENTRALEX MESHES. ON (B)(6) 2006- REPAIR OF INCISIONAL HERNIA WITH VENTRALEX MESH. ON (B)(6) 2009- SUDDEN ONSET OF PAIN, PALPABLE MASS ANTERIORLY. CT OF ABDOMEN/PELVIS. ANTERIOR ABDOMINAL WALL SUPERFICIAL SOFT TISSUE EDEMA AND FLUID COLLECTION, POSSIBLE HEMATOMA, INFECTION, PHLEGMON, OR EARLY ABSCESS. ON (B)(6) 2009 - ABDOMINAL WALL/ABSCESS CULTURE - (B)(6). ON (B)(6) 2009 - DRAINAGE OF ABDOMINAL WALL ABSCESS. ON (B)(6) 2009 - CULTURE OF ABDOMINAL WOUND. MODERATE (B)(6). ON (B)(6) 2009 - INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS. ON (B)(6) 2010 - INCISION & DRAINAGE OF COMPLETE ABSCESS WITH REMOVAL OF 5 PIECES OF INFECTED MESH; REPAIR OF HERNIA WITH VERITAS BIOMESH & PLACEMENT OF WOUND VAC. WOUND (B)(6). OPERATIVE SURGERY INDICATES IRREGULAR FIBROSIS & FOREIGN BODY REACTION WITH FOREIGN MATERIAL CONSISTENT WITH MESH, NO ACUTE INFLAMMATION OR NECROSIS SEEN. ON (B)(6) 2010 - TREATED FOR (B)(6) AT HOME; ER VISITS, IV VANCOMYCIN VIA PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43LOD364

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention