BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2076898 · Received May 4, 2011

    Report

    Report Number
    2210968-2011-00559
    Event Type
    Injury
    Date Received
    May 4, 2011
    Report Date
    April 7, 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

    THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, PRODUCT CODE PFRA01, BATCH 3135684, MFG DATE NI, EXP DATE NI. TENSION FREE VAGINAL TAPE/OBTURATOR, PRODUCT CODE 810081, BATCH 3171188, MFG DATE 06/17/2008, EXP DATE 05/31/2009, 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). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, PRODUCT CODE PFRA01, BATCH 3135684. TENSION FREE VAGINAL TAPE/OBTURATOR, PRODUCT CODE 810081, BATCH 3171188.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED A BOWEL PERFORATION IN 06/2009 AND NEEDED A RIGHT HEMICOLECTOMY WITH AN ILEOSTOMY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR PRODUCT CODE PFRA01, BATCH 3135684, MFG DATE 04/11/2008, EXP DATE 03/31/2011. TENSION FREE VAGINAL TAPE/OBTURATOR PRODUCT CODE 810081, BATCH 3171188, MFG DATE 06/17/2008, EXP DATE 05/31/2009. 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) - THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR PRODUCT CODE PFRA01, BATCH 3135684, TENSION FREE VAGINAL TAPE, PRODUCT CODE NI, BATCH NI.

    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. 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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL PAIN, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, LEG PAIN, DIFFICULTY WALKING, PAINFUL SEXUAL INTERCOURSE, DEVELOPMENT OF A FISTULA, DYSPAREUNIA AND THE NEED FOR MULTIPLE PROCEDURES, TESTS, MEDICATIONS AND MEDICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT LOOP ILEOSTOMY FROM (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2009-(B)(6) 2010 FOR ABDOMINAL PAIN, INTRA-ABDOMINAL ADHESIONS, VENTRAL INCISIONAL HERNIA AND INTRA-ABDOMINAL INFECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT COLOSTOMY, COLOSTOMY REVERSAL, REPAIR OF INCISIONAL HERNIA AND OPEN CHOLECYSTECTOMY FROM (B)(6) 2010-(B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, A PELVIC FLOOR MESH AND A SLING WERE INSERTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, 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