MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN UGYTEX MESH PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN UGYTEX MESH PRODUCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); No Code Available (3191)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse source international urogynecology journal, 2019 (1-9).Date of online publication: 10 september 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source, the aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh or native tissue repair.The study compared anterior colporrhaphy and trans-obturator vaginal mesh for the treatment of anterior vaginal wall prolapse.There were 75 women included in the study analysis, 39 of which were implanted with mesh.There were post-operative complications reported that require re-intervention including pelvic organ prolapse, mesh exposure, hematoma, stress urinary incontinence, dyspareunia and exposure.There were post-operative complications reported as well that did not require re-intervention including urinary tract infections, spontaneous/provoked pain and dyspareunia.

• Brand Name: UNKNOWN UGYTEX MESH PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9336715
• MDR Text Key: 166831237
• Report Number: 9615742-2019-03764
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN UGYTEX MESH PRODUCT
• Device Catalogue Number: UNKNOWN UGYTEX MESH PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention