BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 6329922 · Received February 14, 2017

    Report

    Report Number
    9617613-2017-05000
    Event Type
    Injury
    Date Received
    February 14, 2017
    Report Date
    February 8, 2017
    Manufacturer
    TISSUE SCIENCE LABOR (INACTIVE)
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4). SECTION D4: LOT NUMBER NOT PROVIDED. SECTION D4: UDI NOT PROVIDED. SECTION D8: RE-PROCESSING INFORMATION NOT PROVIDED. SECTION H4: SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED. SECTION E2, E3: OCCUPATION OF INITIAL REPORTER NOT PROVIDED. EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER) C.R. BARD REFERENCE NUMBER: 921611 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, URINARY TRACT INFECTION, BACTERIAL INFECTION, DYSURIA, CHILLS, FLANK PAIN (PAIN), FREQUENCY (URINARY FREQUENCY), NAUSEA, FATIGUE, URGENCY (URINARY URGENCY), AND REQUIRED NON-SURGICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH, NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: PE:(B)(4).A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS ENDOMETRIOSIS, CHRONIC PELVIC PAIN, AND GENUINE URINARY STRESS INCONTINENCE. THE PROCEDURE PERFORMED WAS A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, LAPAROSCOPIC APPENDECTOMY, PUBOVAGINAL SLING REPAIR WITH PLACEMENT OF SUPRAPUBIC CATHETER, CYSTOSCOPY, AND ANTERIOR COLPORRHAPHY. THE PATIENT RETURNED FOR AN OFFICE VISIT ON (B)(6) 2013 FOR AN OFFICE VISIT FOR DYSURIA, A<(>&<)>P/IMP, UTI (LOWER URINARY TRACT INFECTION), DYSURIA, AND FLANK PAIN.

    Description of Event or Problem · 1

    ALLEGED OUTCOMES ATTRIBUTED TO DEVICE INCLUDE PAIN, INFECTION, URINARY PROBLEMS, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111367 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL TISSUE SCIENCE LABOR (INACTIVE) UNK PELVICOL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other AMS IN FAST