MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number UGYKA

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Cyst(s) (1800); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Injury (2348); Disability (2371); Fungal Infection (2419); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); Fibrosis (3167); No Code Available (3191); Constipation (3274)

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. The product was used for therapeutic treatment of urogynecological. It was reported that after implant, the patient experienced uterine prolapse, pelvic relaxation, pelvic pain, stress urinary incontinence and menometrorrhagia. Treatment includes revision.

Manufacturer Narrative

Corrected from previous report. 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 stress urinary in continence. The patient has experienced injury, pain, disability, impairment, uterine prolapse, pelvic relaxation, pelvic pain, menometrorrhagia, recurrent urinary tract infections, mesh erosion, umbilical hernia, having lost her g-spot, decreased libido, severe dyspareunia, vaginal dryness, severe yeast infection, hypoestrogenic, sensation of pelvic floor falling, sensation of something poking her, partner feeling something, mesh exposure with excision, overactive bladder, recurrent stress urinary incontinence, frequency, mixed incontinence, recurrent pelvic prolapse, sexual dysfunction, urgency, recurrent rectocele, sensation of a bulge in the posterior aspect of the rectum, and ventral hernia. Post-operative patient treatment included nonsurgical and surgical interventions, including hormone pellet therapy.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of stress urinary in continence. The patient has experienced injury, pain, disability, impairment, uterine prolapse, pelvic relaxation, pelvic pain, menometrorrhagia, recurrent urinary tract infections, mesh erosion, umbilical hernia, having lost her g-spot, decreased libido, severe dyspareunia, vaginal dryness, severe yeast infection, hypoestrogenic, sensation of pelvic floor falling, sensation of something poking her, partner feeling something, mesh exposure with excision, overactive bladder, recurrent stress urinary incontinence, frequency, mixed incontinence, recurrent pelvic prolapse, sexual dysfunction, urgency, recurrent rectocele, sensation of a bulge in the posterior aspect of the rectum, small uterine fibroid, adenomyosis, endocervicitis, hemorrhagic corpus luteum cyst, left paratubal cystic change, inflammation, fibrous tissue, burning with urination, constipation, right ureteral orifice was somewhat laterally displaced, and ventral hernia. Post-operative patient treatment included nonsurgical and surgical interventions, laparoscopic assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, hormone pellet therapy, and implantation of new xenform mesh.

Manufacturer Narrative

(b)(4). Concomitant prod: uretexsup uretex support pp kit x1 (lot# sga00160), ugykp parietex ugytex pp post kit x1 (lot# zga00037). If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7838767
• MDR Text Key: 118948451
• Report Number: 9615742-2018-01966
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2011
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZGA00038
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/31/2018 Patient Sequence Number: 1