BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2113259 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00716
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: GYNECARE GYNEMESH PRODUCT CODE - GPSL, BATCH TCB139. TENSION FREE VAGINAL TAPE PRODUCT CODE - 810081, BATCH 1189156.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION:THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLENE MESH - (B)(4), TENSION FREE VAGINAL TAPE - (B)(4). THE MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: GYNECARE GYNEMESH: PRODUCT CODE GPSL, BATCH TCB139. TENSION FREE VAGINAL TAPE: PRODUCT CODE - NI, BATCH 1189156. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE FOR PELVIC ORGAN PROLAPSE ON (B)(6) 2004. DURING THE PROCEDURE, MESH, A SLING, AND AN APOGEE STEM WITH INTEPRO LITE WERE IMPLANTED. THE PATIENT EXPERIENCED A PELVIC INFECTION, EROSION OF THE MESH, INFLAMMATION, NERVE DAMAGE, MIGRATION, AUTOIMMUNE DISEASE DEVELOPMENT, AND MULTIPLE SURGERIES TO REMOVE MESH. THE PATIENT HAD A SECOND PROCEDURE IN 2008 DURING WHICH APOGEE STEM WITH INTEPRO LITE WAS USED. THE MESH WAS EXPLANTED ON (B)(6) 2010. THE EVENT DID NOT ABATE AFTER EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention APOGEE STEM WITH INTEPRO LITE