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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
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.
 
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Brand NameMESH SOFRADIM - UGYTEX¿
Type of DeviceMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key7838767
MDR Text Key118948451
Report Number9615742-2018-01966
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K051503
Number of Events Reported1
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 Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2011
Device Model NumberUGYKA
Device Catalogue NumberUGYKA
Device Lot NumberZGA00038
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No

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