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

Model Number UGYKA

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Irritation (1941); Urinary Frequency (2275); Injury (2348); Irritability (2421); Tissue Breakdown (2681)

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 resulting in an unspecified outcome.Product was used for therapeutic treatment.The mesh was implanted as the patient had stress urinary incontinence (sui), rectal dysfunction, cystocele and enterocele.The procedure (s) performed were anterior and posterior mesh placement, mid urethral sling placement, enterocele ablation and cystoscopy.Postoperative complications patient experienced were - in 2007 -urinary frequency, urgency, post void dribbling, bladder irritability, mid urethral sling that was visible through the vaginal mucosa and possibly either a wound breakdown at that site or possibly a rejection - pelvic shows the anterior vagina, there is a mid urethral sling which is being extruded through the submucosa, the mid urethral sling which is being extruded at this time in an area of approximately 10-12 mm by approximately 3 mm ¿ plan for mid urethral sling revision and cystoscopy.Patient had mesh revision surgery (uretex to2) in 2007 - underwent resection of mid urethral sling for extrusion under general anesthesia (interim medical records from 01/23/2007 to 04/08/2014 pertaining to tvm is not available to know the clinical condition of the patient).Following the mesh revision surgery, she developed complications that required additional surgery.Complications includes urinary incontinence, mesh exposure in left anterior fornix of the vagina just behind the pubic bone during 2007 ¿2014 for which she had undergone the following additional surgeries.Additional mesh (uretex to2) revision surgery in 2014 where patient had underwent excision of exposed vaginal mesh for vaginal mesh exposure under general anesthesia (further medical records are not available for review).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7739388
• MDR Text Key: 115700677
• Report Number: 9615742-2018-01777
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2015
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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; Required Intervention
• Patient Age: 50 YR