BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2064765 · Received April 20, 2011

    Report

    Report Number
    2210968-2011-00480
    Event Type
    Injury
    Date Received
    April 20, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT CODE PFRA01, BATCH 2931627, EXP DATE 05/31/2007, MFG DATE 06/26/2006; TENSION FREE VAGINAL TAPE/OBTURATOR: PRODUCT CODE 810081, BATCH 2951916, EXP DATE 07/31/2007, MFG DATE 08/28/2006. 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). DUE TO MESH PROTRUSION, PELVIC AND VAGINAL PAIN, DYSPAREUNIA AND DEVELOPMENT OF FISTULA, MESH WAS REMOVED BY ON (B)(6) 2007, (B)(6) 2011 AND ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/20/2011. (B)(4). 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. ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR; TENSION FREE VAGINAL TAPE.

    Additional Manufacturer Narrative · 1

    (B)(4) - THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR PRODUCT CODE PFRA01, BATCH 2931627, EXP DATE NI, MFG DATE NI TENSION FREE VAGINAL TAPE/OBTURATOR PRODUCT CODE 810081, BATCH 2951916, EXP DATE 07/31/2007, MFG DATE 08/28/2006. 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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2006 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, PELVIC FLOOR REPAIR MESH AND A SLING WERE INSERTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN 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