MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿; MESH, SURGICAL, POLYMERIC

Model Number UGYKP

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

Patient Problems Erosion (1750); Purulent Discharge (1812); Micturition Urgency (1871); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348)

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 menorrhagia, fibroid uterus, cystocele, rectocele, vaginal vault prolapse.It was reported that after implant, the patient experienced erosion of posterior synthetic mesh into vagina, chronic continuous foul smelling vaginal discharge, frequency-urgency syndrome, and exposed mesh bunching fibers in the middle and bleeding to touch.Post-operative treatment included additional surgery.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• 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: 8869878
• MDR Text Key: 153545891
• Report Number: 9615742-2019-02776
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• 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
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Device Lot Number: ZGH00398
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Date Device Manufactured: 09/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention