BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2212008 · Received August 15, 2011

    Report

    Report Number
    2210968-2011-01098
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON INC
    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

    DATE SENT TO THE FDA: (B)(4) 2011. (B)(4) - UNSPECIFIED INJURIES OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, PRODUCT CODE PFRA01, BATCH 3238528; TENSION FREE VAGINAL TAPE /OBTURATOR PRODUCT CODE 810081, BATCH 3238455,

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, PRODUCT CODE PFRA01, (B)(4), EXP DATE 10/31/2011, MFG DATE 11/18/2008. TENSION FREE VAGINAL TAPE /OBTURATOR, PRODUCT CODE 810081, (B)(4), EXP DATE 10/31/2009, MFG DATE 11/19/2008. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH REMOVAL SURGERIES ON (B)(6) 2009 AND (B)(6) 2011 DUE TO VAGINAL MESH EROSION, PAIN, BLEEDING, AND DYSPAREUNIA. (B)(4) DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT ALSO UNDERWENT COOK MEDICAL SURGISIS REPAIR GRAFT IMPLANTATION ON (B)(6) 2011 DUE TO VAGINAL MESH EROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR STRESS INCONTINENCE ON (B)(6) 2009 AND A SLING AND A PELVIC FLOOR MESH WERE IMPLANTED INTO THE PATIENT. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. 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 INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention