BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3152778 · Received June 8, 2013

    Report

    Report Number
    2210968-2013-06729
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    October 14, 2024
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF VOLUNTARY FACILITY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 DATE FOR A CYSTOCELE AND MESH WAS IMPLANTED. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR VAGINAL EXTRUSION OF THE MESH. THE EXTRUSION WAS DESCRIBED AS A ONE FORTH THE SIZE OF A PENNY. THE MESH WAS EXCISED, ANTIBIOTIC IRRIGATION WAS PERFORMED, AND THE DEFECT WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254601 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3238528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention