BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2971735 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01306
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH SACROSPINOUS SUSPENSION, PERINEORRHAPHY, RIGHT SIDED EXTRAPERITONEAL SACROSPINOUS LIGAMENT, FIXATION TO THE VAGINAL VAULT AND CYSTOURETHROSCOPY DUE TO STAGE II RECTOCELE, STAGE II VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED TROUBLE STARTING URINARY STREAM, INABILITY TO EMPTY BLADDER, GENITAL SORES, URINARY URGENCY, INABILITY TO CONTROL BLADDER, URINARY FREQUENCY. (B)(4). EXPERIENCED TROUBLE STARTING URINARY STREAM, INABILITY TO EMPTY BLADDER, GENITAL SORES, INABILITY TO CONTROL BLADDER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND URGE LEAKAGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED TROUBLE STARTING URINARY STREAM, INABILITY TO EMPTY BLADDER, GENITAL SORES, URINARY URGENCY, INABILITY TO CONTROL BLADDER, URINARY FREQUENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND URGE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75719 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3510641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention