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

Model Number UGYKP

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

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Ascites (2596); Blood Loss (2597); 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This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.Concomitant medical products: system t-sling with centrasorb¿.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 incontinence, symptomatic cystocele and rectocele.It was reported that after implant, the patient experienced post-op blood loss requiring transfusion of two units of blood, small area of heterogenous fluid collection in left sidewall, foreign body in the genitourinary tract, pelvic pain, dyspareunia, urge incontinence, urinary frequency, frequent urinary tract infections, urinary stream abnormality, stress incontinence.Post-operative patient treatment included surgical intervention.The device had been used with avaulta¿ anterior biosynthetic support system t-sling with centrasorb¿.

Manufacturer Narrative

Correction: (outcome attributed to adverse event change to intervention required).If information is provided in the future, a supplemental report will be issued.

• Brand Name: 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: 9251227
• MDR Text Key: 164166015
• Report Number: 9615742-2019-03554
• Device Sequence Number: 1
• Product Code: OTP
• 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
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Device Lot Number: ZGJ00133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AVAULTA¿ ANTERIOR BIOSYNTHETIC SUPPORT; AVAULTA¿ ANTERIOR BIOSYNTHETIC SUPPORT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR