BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3082110 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04608
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    July 5, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 TOTAL ABDOMINAL HYSTERECTOMY/ BILATERAL SALPINGO-OOPHORECTOMY, AND ANTERIOR COLPORRHAPHY, DUE TO CHRONIC PELVIC PAIN, INTRACTABLE UTERINE BLEEDING, POLYCYSTIC OVARY DISEASE, PELVIC ENDOMETRIOSIS, AND SEVERE STRESS INCONTINENCE SECONDARY TO A THIRD DEGREE CYSTOCELE AND LOSS OF URETHROVESICAL ANGLE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CONTINUOUS BLADDER INFECTIONS REQUIRING ANTIBIOTICS, LEAKAGE, LIVER PROBLEMS, DEPRESSION, SEVERAL INFECTIONS (OVARY), BLADDER SPASMS, AND UNABLE TO ENJOY LIFE. (B)(4). THE ALERT DATE OF THIS FILE HAS BEEN REVIEWED AND UPDATED BASED ON FDA CDRH¿S COMMUNICATION AND REALIGNMENT ON THE DEFINITION OF AWARE DATE WHEN REVIEWING MEDICAL RECORDS FOR LITIGATION COMPLAINTS. THE AWARE DATE IS WHEN ETHICON HAS REVIEWED THE MEDICAL RECORDS AND EITHER DETERMINED THAT AN EVENT IS MDR REPORTABLE OR HAS IDENTIFIED ADDITIONAL OR CORRECTED INFORMATION RELATED TO A PREVIOUSLY SUBMITTED MDR.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. 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 IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183966 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3374591

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention