BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - URETEX

    MDR report key: 6800969 · Received August 17, 2017

    Report

    Report Number
    9615742-2017-05204
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    May 1, 2018
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC COMPLAINT REPORT NUMBER: (B)(4). C64343: NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. TYPE OF DEVICE: UPDATED FROM URETEX SUP URETHRAL SUPPORT SYSTEM TO URETEX TO URETHRAL SUPPORT SYSTEM EXEMPTION NUMBER: E2013003. MEDTRONIC IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC (IMPORTER) C.R BARD REFERENCE NUMBER: ((B)(4)). IMPORTER 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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4). SECTION B3: INCIDENT DATE WAS NOT PROVIDED. 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. EXEMPTION NUMBER: E2013003 COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER) C.R. BARD REFERENCE 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. 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, EXTRUSION, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, BLEEDING (BLOOD LOSS), DYSPAREUNIA, ORGAN PERFORATION (PERFORATION OF ORGAN), AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EROSION, VAGINAL LESION, DEFECT, SCARRING, ELEVATED BLOOD PRESSURE, CHEST PAIN, ANXIETY, DRAINAGE, PAIN, UNSPECIFIED SENSORY CHANGES TO RIGHT THIGH, ELEVATED TEMPERATURE, UNSPECIFIED POSITIVE URINALYSIS, ANEMIA, ABDOMINAL PAIN, HYDROSALPINX, PELVIC PAIN, NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EROSION, VAGINAL LESION, DEFECT, SCARRING, ELEVATED BLOOD PRESSURE, CHEST PAIN, ANXIETY, DRAINAGE, PAIN, UNSPECIFIED SENSORY CHANGES TO RIGHT THIGH, ELEVATED TEMPERATURE, UNSPECIFIED POSITIVE URINALYSIS, ANEMIA, ABDOMINAL PAIN, HYDROSALPINX, PELVIC PAIN, NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED PAIN, EXTRUSION,UNSPECIFIED URINARY PROBLEMS, RECURRENCE, BLEEDING (BLOOD LOSS), DYSPAREUNIA, ORGAN PERFORATION (PERFORATION OF ORGAN), AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PRE-OP DIAGNOSIS: ADENOMYOSIS, UTEROVAGINAL PROLAPSE, GENUINE STRESS URINARY INCONTINENCE, CYSTOCELE, RECTOCELE. PROCEDURE: TOTAL VAGINAL HYSTERECTOMY, SLING PLACEMENT, ANTERIOR, POSTERIOR REPAIR, BILATERAL SACROSPINOUS LIGAMENT FIXATION, PLACEMENT OF MESH X2 AND CYSTOSCOPY PERFORMED WITH FOLEY CATHETER PLACED ON (B)(6) 2007. UTERUS/CERVIX SPECIMENS SENT FOR PATHOLOGY. FINDINGS: GLOBULAR UTERUS CONCOMITANT THERAPY: ETHICON GYNECARE PROLIFT SYSTEM, UNK MESH (X2) OTHER RELEVANT HISTORY: HISTORY OF ABDOMINAL LIPODYSTROPHY, EXCORIATION, SAGGING MONS, HIATAL HERNIA ASSOCIATED WITH WEIGHT LOSS AND GASTRIC SLEEVE PROCEDURE IN 2013, MORBID OBESITY, OBSTRUCTIVE SLEEP APNEA, ASTHMA, LARGE PANNUS, ACID REFLUX SYMPTOMS, PAIN, OSTEOARTHRITIS, APPENDECTOMY, HYPERTENSION, ANXIETY, GASTRITIS, MIGRAINES, GASTRITIS, THYROID NODULE, HERNIA WITH REPAIR X2, OVARIAN CYST, PARA THREE, DYSFUNCTIONAL UTERINE BLEEDING, DIVERTICULOSIS, DIVERTICULITIS, CHOLELITHIASIS. -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 WAS GENUINE ADENOMYOSIS, UTEROVAGINAL PROLAPSE, GENUINE STRESS URINARY INCONTINENCE, CYSTOCELE, AND RECTOCELE. THE PROCEDURE PERFORMED WAS A TOTAL VAGINAL HYSTERECTOMY, SUBURETHRAL SLING PROCEDURE WITH MESH, ANTERIOR REPAIR, POSTERIOR REPAIR, BILATERAL SACROSPINOUS LIGAMENT FIXATION, PLACEMENT OF MESH X 2, AND CYSTOSCOPY. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2013. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2014. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS EROSION OF VAGINAL MESH AND LESION IN VAGINA. THE PROCEDURE PERFORMED WAS AN EXCISION OF VAGINAL MESH AND BIOPSY OF VAGINA. MEDICAL HISTORY: DIVERTICULOSIS. MORBID OBESITY SURGICAL HISTORY: APPENDECTOMY (1997); ABD HERNIA REPAIR. LAPAROSCOPIC SLEEVE GASTRECTOMY AND HIATAL HERNIA REPAIR ((B)(6) 2013).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580326 MESH SOFRADIM - URETEX MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN SOFRADIM PRODUCTION SAS UNKURETEXTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R ETHICON GYNECARE PROLIFT SYSTEM, MESH| ETHICON GYNECARE PROLIFT SYSTEM, MESH