BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2255887 · Received September 20, 2011

    Report

    Report Number
    2210968-2011-01330
    Event Type
    Injury
    Date Received
    September 20, 2011
    Report Date
    August 29, 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 (B)(4), BATCH 2965523, EXP DATE 09/30/2007, MFG DATE 10/12/2006. TENSION FREE VAGINAL TAPE PRODUCT CODE (B)(4), BATCH 2971842, EXP DATE 10/31/2008, MFG DATE 11/28/2006. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT BILATERAL PARAVAGINAL DEFECT, URINARY INCONTINENCE, ENTEROCELE, CYSTOCELE, RECTOCELE. CONCURRENT PROCEDURES WERE PROCTOSCOPY, REMOVAL OF BLADDER TUMOR, SIGMOIDOSCOPY. PATIENT EXPERIENCED PELVIC PAIN, DYSURIA, DYSPAREUNIA, MULTIPLE URINARY TRACT INFECTIONS. IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED FOR SEVERE URINARY TRACT INFECTION WITH RESPIRATORY DISTRESS ON (B)(6) 2011. ON (B)(6) 2011, PATIENT HAD PARTIAL REMOVAL OF MESH.

    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: PROLIFT PELVIC FLOOR REPAIR PRODUCT CODE PFRT01, BATCH 2965523, EXP DATE UNK, MFG DATE UNK. TENSION FREE VAGINAL TAPE PRODUCT CODE TVTS1, BATCH 2971842, EXP DATE 10/31/2008, MFG DATE 11/28/2006. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 DURING WHICH PELVIC FLOOR REPAIR MESH AND A SLING WERE USED. THE PATIENT EXPERIENCED EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    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