MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS URETEX MESH, SURGICAL, POLYMERIC

Model Number URETEXTO2

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

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Incontinence (1928); Inflammation (1932); Pain (1994); Scar Tissue (2060); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); 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This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.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. 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 incontinence. It was reported that after implant, the patient experienced recurrence, pelvic pain, dyspareunia, abnormal uterine bleeding, adhesions, urethral hypermobility and intrinsic sphincter deficiency, defecatory disorder secondary to rectocele, left bartholin gland inflammation, and vaginal scar tissue. Post-operative patient treatment included video urodynamic evaluation including noninvasive uroflowmetry, cystometrogram, sphincteric emg monitoring, abdominal leak point pressure measurement, pressure flow urodynamics, urethrocystography and video imaging, a transobturator mesh revision and cystoscopy, pubovaginal sling with align retropubic urethral support system, cystoscopy, and posterior colpoperineorrhaphy, an examination under anesthesia, excision of mesh on the left lateral wall of the vagina and left obturator space, excision of left inflamed bartholin gland, and cystoscopy, and laparoscopy with lysis of adhesions.

• Brand Name: URETEX
• 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: 8925443
• MDR Text Key: 155346366
• Report Number: 9615742-2019-02873
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/01/2012
• Device Model Number: URETEXTO2
• Device Catalogue Number: URETEXTO2
• Device Lot Number: SHC00038
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/23/2019 Patient Sequence Number: 1