BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2070827 · Received April 27, 2011

    Report

    Report Number
    2210968-2011-00517
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).RESULTS: THE EXPLANTED MESH SHOWED THE NON-RESORBABLE, LARGE PORE, MONOFILAMENT POLYPROPYLENE MESH WHICH SHOWS MINIMAL FOREIGN BODY REACTION. THE IMMUNOHISTOCHEMICAL DETECTION OF THE PERITONEUM ON BOTH THE VISCERAL AND PARIETAL SIDE OF MESH INDICATES THAT THE MESH HAS NOT BEEN PLACED FLAT AGAINST THE ABDOMINAL WALL. A RELATION TO THE USED FIXATION (ABSORBATACKS) CANNOT BE DRAWN. CONCLUSION- THE RECURRENCE SEEMS TO BE DUE TO INADEQUATE FIXATION AS IN THE HISTOLOGICAL EXAMINATION PERITONEUM CELLS WERE FOUND ON BOTH SIDES OF THE MESH.

    Additional Manufacturer Narrative · 1

    (B)(4). RECURRENT HERNIA. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SURGICAL PROCEDURE ON (B)(6) 2010 TO REPAIR A VENTRAL HERNIA AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A RECURRENT HERNIA ON AN UNKNOWN DATE. THE PATIENT UNDERWENT AN OPEN HERNIA REPAIR PROCEDURE (B)(6) 2011. DURING THE PROCEDURE, THE MESH WAS VERY EASILY REMOVED BECAUSE IT WAS HARDLY ATTACHED TO THE PERITONEUM WITH ALMOST NO INGROWTH. A DIFFERENT MESH WAS USED COMPLETE THE REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ABSORBATACK