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

Model Number UGYKP

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

Patient Problems Abdominal Pain (1685); Edema (1820); Incontinence (1928); Inflammation (1932); Pain (1994); Scarring (2061); Urinary Retention (2119); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The indication for implantation of transvaginal mesh in this patient was urinary stress incontinence and pelvic prolapse.Procedure: underwent sub-urethral tape cystoscopy using obtryx (obturator approach), enterocele repair, rectocele repair using avaulta mesh and perineorrhaphy under general endotracheal anesthesia.Complications post implant: dyspareunia and vaginal stitch.First mesh revision surgery on (b)(6) 2008: underwent removal of mesh under general mask anesthesia for dyspareunia and vaginal stitch.Complications post first mesh revision surgery: patient complains of dyspareunia.Additional surgery: (b)(6) 2009: underwent perineoplasty for dyspareunia secondary to perineal scarring.Complications post additional surgery: mild edema, severe dysmenorrhea and chronic vaginal pain, pelvic pain, obstruction, dyspareunia, stress incontinence, scarring, inflammation.Second mesh revision surgery on (b)(6) 2010: underwent revision and partial removal of vaginal mesh, rectocele repair for inflammation of genitourinary device, mesh exposure and rectocele under iv sedation with epidural and local anesthesia.Complications post second mesh revision surgery: dyspareunia, pain.Third revision surgery on (b)(6) 2010: underwent vaginal mesh revision for pelvic pain status post mesh repair under local with sedation.Complications post third mesh revision surgery: pain, pelvic pain, scarring.Fourth mesh revision surgery on (b)(6) 2011: underwent excision of vaginal mesh x 180 minutes performed vaginally, robotic assisted laparoscopy, excision of the pelvic portion of mesh, performed vaginally, robotic assisted laparoscopy, excision of the pelvic portion of mesh done robotically, obturator neurolysis, placement of platelet rich plasma graft on the nerve, encasing the nerve in neuragen, cystoscopy, proctoscopy to 10 cm, botox injection into pelvic floor muscles and bilateral pudendal nerve block for chronic pelvic pain, obturator neuralgia, pelvic floor tension myalgia and retained vaginal mesh under general endotracheal tube.

• 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
• 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: 7608581
• MDR Text Key: 111303806
• Report Number: 9615742-2018-01326
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2015
• 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): Other
• Patient Age: 43 YR