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

Model Number UGY1510

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

Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 post hysterectomy vaginal vault prolapse and pelvic pain.It was reported that after implant, the patient experienced persistent uti's, cystocele, dyspareunia, dysuria, pelvic prolapse, intermittent pelvic pain, chronic cystitis, vaginal structure/atresia, pressure on vagina when sitting, back pain/pressure, urinary urgency, urinary frequency, right inguinal bulging, right-sided abdominal distention, and right inguinal hernia.Post-operative patient treatment included transvaginal removal of synthetic mesh, anterior colporrhaphy and right inguinal hernia repair.

• 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: 8899720
• MDR Text Key: 154531502
• Report Number: 9615742-2019-02844
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: UGY1510
• Device Catalogue Number: UGY1510
• Device Lot Number: PJD00471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Date Device Manufactured: 04/01/2009
• 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
• Patient Age: 53 YR
• Patient Weight: 72