BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2060229 · Received April 15, 2011

    Report

    Report Number
    2210968-2011-00437
    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

    THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT: CATALOG NUMBER: PFRA01, LOT NUMBER: 1380722, EXPIRATION DATE: 12/31/2006, MANUFACTURER DATE: 01/13/2006, APPROXIMATE AGE OF DEVICE: 2 MONTHS. TENSION FREE VAGINAL TAPE: CATALOG NUMBER: 810081, LOT NUMBER: 1387061, EXPIRATION DATE: 12/31/2006, MANUFACTURER DATE: 01/24/2006, APPROXIMATE AGE OF DEVICE: 2 MONTHS. 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). 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 /OBTURATOR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERSTIM 1 AND INTERSTIM 2 ON (B)(6) 2008 DUE TO URGENCY AND FREQUENCY. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOURETHROSCOPY WITH HOLMIUM LASER LITHOTRIPSY OF BLADDER CALCULI AND RESECTION OF ERODED MESH, REMOVAL OF INTERSTIM IPGN WIRE ON (B)(6) 2012 DUE TO MESH EROSION IN THE BLADDER WITH STONE FORMATION, NONFUNCTIONING INTERSTIM. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF URETHRAL MESH, URETHRAL RECONSTRUCTION, COMPLEX CYSTORRHAPHY WITH EXCISION OF BLADDER MESH, PLACEMENT OF SUPRAPUBIC TUBE, MARTIUS LABIAL FAT PAD INTERPOSITION GRAFT ON (B)(6) 2012 DUE TO ERODED MESH IN BOTH BLADDER AND URETHRA. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPY, EXPLORATORY LAPAROTOMY WITH ABDOMINAL WASHOUT AND ILEOCECAL RESECTION, RIDGED SIGMOIDOSCOPY ON (B)(6) 2012 DUE TO SURGICAL ABDOMEN, AND PERFORATED CECUM WITH ABDOMINAL CONTAMINATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATION WITH ABDOMINAL WASHOUT, RIGHT HEMICOLECTOMY ON (B)(6) 2012 DUE TO OPEN ABDOMEN STATUS POST ILEOCECTOMY FOR PERFORATED CECUM. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL HERNIA REPAIR ON (B)(6) 2013. THERE ARE TWO POSSIBLE DEVICES ASSOCIATED WITH THIS EVENT. THEY ARE AS FOLLOWS: PROLIFT - (B)(4) ¿ URINARY PROBLEMS. TENSION FREE VAGINAL TAPE - (B)(4) ¿ URINARY PROBLEMS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL SURGERIES DUE TO MESH ERODING INTO THE BLADDER ON (B)(6) 2006, (B)(6) 2006, (B)(6) 2006, (B)(6) 2007, (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2006 AND AN OBTURATOR SLING AND PELVIC FLOOR MESH WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT 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