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

Model Number URETEXTO2

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

Patient Problems Erosion (1750); Breast Cancer (1759); Cellulitis (1768); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Weakness (2145); Cramp(s) (2193); Discharge (2225); Anxiety (2328); Distress (2329); Injury (2348); Disability (2371); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); 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 prolapsed uterus and urinary incontinence. It was reported that after implant, the patient experienced device failure, pain, bleeding, protrusion, fear of sexual intercourse, upset emotional distress, embarrassment, uterus again bulging, inability to lift or strain, recurrent urinary incontinence, recurrent prolapse, erosion, stage i breast cancer, hypertension, and vaginal pain. Post-operative patient treatment included hysterectomy, device removal, and estrogen cream.

• Brand Name: MESH SOFRADIM - 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: 8697967
• MDR Text Key: 147993763
• Report Number: 9615742-2019-02189
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2011
• Device Model Number: URETEXTO2
• Device Catalogue Number: URETEXTO2
• Device Lot Number: SGH00297
• 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: 01/29/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/01/2006
• 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: 06/13/2019 Patient Sequence Number: 1