BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 5201773 · Received November 4, 2015

    Report

    Report Number
    1219977-2015-00316
    Event Type
    Injury
    Date Received
    November 4, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS EVENT AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. CLINICAL EVALUATION: HERNIAS EMERGE THROUGH PREFORMED OR ACQUIRED DEFECTS OR WEAK AREAS OF THE ABDOMINAL WALL UNPROTECTED BY MUSCLE OR APONEUROSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS FOLLOWING THE REPAIR OF A HERNIA. COMPLICATIONS MAY OCCUR DUE TO A TECHNICAL ERROR, INADEQUATE SUTURE FIXATION AND/OR INADEQUATE OVERLAP WHICH WILL CAUSE SEPARATION OF THE MESH FROM THE ABDOMINAL WALL THEREBY INCREASING THE POSSIBILITY OF INFECTION, PERFORATION, SEROMA, ADHESIONS, FISTULA FORMATION AND PAIN. THE COMPROMISED PATIENT UNDERGOING A SECOND SURGERY FOR EXPLANT HAS INCREASED RISKS. THE INSTRUCTIONS FOR USE STATE COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO, INFLAMMATION, INFECTION OR MECHANICAL DISRUPTION OF THE TISSUE AND/OR MESH MATERIAL, POSSIBLE ADHESIONS WHEN PLACED IN DIRECT CONTACT WITH THE VISCERA (INTESTINES).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE MANUFACTURING LOT HISTORY RECORDS WAS CONDUCTED. THE RELEASE CRITERIA WAS MET.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT. A REVIEW OF THE MEDICAL RECORD REVEALS NO REFERENCE TO THE MESH "FLOATING" DURING A LAPAROSCOPIC BLADDER NECK SUSPENSION AND LATERAL VAGINAL WALL REPAIR. STRIPS OF PROLITE MESH WERE SECURED WITH AN ORIGIN TACKER (ORIGIN MEDSYSTEMS, INC.). THIS IS A 5-MM FIXATION DEVICE THAT USES A HELICAL COIL AS FIXATION. THIS IS CONSISTENT WITH THE X-RAY FINDINGS.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT MESH WAS IMPLANTED FOR BLADDER PIN UP IN 1998. SHE IS ON ANTIBIOTICS AND HAS BEEN TOLD THAT THE MESH IS FLOATING IN HER PELVIC AND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731576 PROLITE MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 1510606-13 731407

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention