BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3103409 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05307
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2007 IN ORDER TO TREAT CYSTOCELE, ENTEROCELE, FASCIAL WEAKNESS, AND STRESS URINARY INCONTINENCE CONCURRENTLY WITH ANTERIOR COLPORRHAPHY, LEVATOR MYORRHAPHY, AND A CYSTOSCOPY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT BREAST LUMPECTOMY IN 2007 AND A NECK MELANOMA EXCISION IN 2009. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SQUAMOUS CELL CANCER AND MELANOMA IN 2008 AND 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION AND CYSTOSCOPY ON (B)(6) 2012 FOR SUI, INTRINSIC SPHINCTER DEFICIENCY, AND MECHANICAL COMPLICATION OF SLING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2007 AND (B)(6) 2012 AND MESH, AMS SPARC, BARD ALIGN, BOSTON SCIENTIFIC OBTRYX AND COLOPLAST ARIS WERE IMPLANTED. IT WAS REPORTED THAT SHE 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.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/26/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND PERIGREE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AND SOLYX SIS SYSTEM WAS 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
    203258 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3033964

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention