BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2060221 · Received April 15, 2011

    Report

    Report Number
    2210968-2011-00436
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: GYNECARE GYNEMESH, TENSION FREE VAGINAL TAPE /OBTURATOR.

    Additional Manufacturer Narrative · 1

    THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: GYNECARE GYNEMESH - PRODUCT CODE GPSXL3; BATCH ALB824, MFG DATE: 10/01/2008, EXP DATE: 10/31/2013. TENSION FREE VAGINAL TAPE /OBTURATOR - PRODUCT CODE 810081; BATCH 3270025, MFG DATE: 02/24/2009, EXP DATE: 01/31/2010. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCURRENT TO MESH IMPLANTATION THE PATIENT HAD A HYSTERECTOMY. THE PATIENT HAD MESH REMOVED ON (B)(6) 2009 AND (B)(6) 2010 DUE TO MESH EROSION, URINARY AND FECAL INCONTINENCE AND DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2009 AND AN OBTURATOR SLING AND PELVIC FLOOR REPAIR MESH WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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