MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿; MESH, SURGICAL, POLYMERIC

Model Number UGY1510

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Granuloma (1876); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Ulcer (2274); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); Intermenstrual Bleeding (2665); Dysuria (2684); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038b) and is now being submitted on a 3500a form because of newly received information - exemption number: e2013003.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of uterine prolapse, cystocele, rectocele, stress urinary incontinence.It was reported that after implant, the patient experienced vaginal bleeding (blood loss), vaginal discharge, foreign body in patient, granuloma, erosion of the mesh at the level of the vaginal apex, pelvic pain, dyspareunia, pain, infection, unspecified bowel problems, blood loss, unspecified neuromuscular problems, stress urinary incontinence, pelvic organ prolapse, abdominal pain, peritoneal vaginal fistula, infection, vaginal scarring (scar tissue), adhesions, inflammation, ulcer, uti, dysuria, abdominal pressure, urinary frequency, back and hip pain, suprapubic tenderness, slightly tender incision, right costovertebral angle tenderness, major depressive disorder, problems concentrating, forgetfulness, suicidal thoughts, generalized anxiety, suture erosion at the vaginal apex, palpable painful areas (vaginal apex), right flank pain, abnormal vaginal bleeding requiring areas cauterized every couple of months, frustration, always needing to have pad on, peritoneal vaginal fistula requiring removal, menopausal atrophy of the vagina, vaginal defect on the right side of the vaginal apex, extensive omental adhesion attaching the omentum to the upper and lower abdomen, bladder, right and left pelvic side wall, cramping, mesh exposure through vaginal wall and multiple non-surgical and surgical interventions.The device had been used with suprapubic catheter, davol drain, and align urethral support system retropubic.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8670215
• MDR Text Key: 147047895
• Report Number: 9615742-2019-01795
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: UGY1510
• Device Catalogue Number: UGY1510
• Device Lot Number: PJE00354
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR