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

Model Number UNKNOWN UGYTEX ANTERIOR/POSTERIOR MESH

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4) march 2016 submission) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.New info: information was also received indicating that the mesh involved in this incident is not a medtronic/covidien product.No further reports will be sent for this event.This was previously reported through an alternative summary report as a mesh sofradim - ugytex (procode ftl) mesh device.The actual device involved is a non-medtronic avaulta solo mesh device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced prolapse, incontinence, pelvic pain, bleeding, pain during sexual relations, depression, anxiety, pain, bleeding in vagina during sexual relations (intermenstrual bleeding), bowel obstruction, cystocele/rectocele (prolapse), hernias, hypotension/low blood pressure, anemia, recurrent vaginal pain, severe piercing cramps (cramp), pulling sensation (foreign body sensation), urinary incontinence, vaginal vault prolapse, failed mesh (failure of implant), and required nonsurgical interventions.

• 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: 10742758
• MDR Text Key: 213405381
• Report Number: 9615742-2020-02410
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN UGYTEX ANTERIOR/POSTERIOR MESH
• Device Catalogue Number: UNKNOWN UGYTEX ANTERIOR/POSTER
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• 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): Other
• Patient Age: 45 YR
• Patient Weight: 73