BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 6122106 · Received November 22, 2016

    Report

    Report Number
    9617613-2016-00105
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    February 28, 2019
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN SECTIONS PATIENT IDENTIFIER,AGE OR DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, EVENT, OTHER RELEVANT HISTORY. EXEMPTION NUMBER: E2013003. MEDTRONIC IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC (IMPORTER) C.R. BARD REFERENCE NUMBER: (B)(4). UF/IMPORTER REPORT NUMBER: (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). C.R. BARD REFERENCE NUMBER: (B)(4). SECTION A: PATIENT INFORMATION NOT PROVIDED. SECTION D4: UDI, LOT NUMBER NOT PROVIDED. SECTION F3: USER FACILITY NOT PROVIDED. SECTION H4: SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF STRESS URINARY INC ONTINENCE, SYMPTOMATIC CYSTOCELE AND SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INJURY, PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA, INFECTION, UTI, EROSION, AND URINARY INCONTINENCE. THE DEVICE HAD BEEN USED WITH GYNECA RE TVT OBTURATOR 810081, LOT#: 3323217. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERIES.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT, URINARY PROBLEMS, AND DYSPAREUNIA. PATIENT HAS REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA, ADDITIONAL SURGERIES, EROSION, AND URINARY INCONTINENCE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771722 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR 482812 09B04-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R