MAUDE Adverse Event Report: SOFRADIM PRODUCTION UGYTEX MESH PRODUCT

Catalog Number UNKNOWN UGYTEX

Device Problem Material Rupture (1546)

Patient Problems Erosion (1750); Fever (1858); Hematoma (1884); Pain (1994); Therapeutic Response, Decreased (2271); Prolapse (2475); Blood Loss (2597)

Event Type  Injury  

Event Description

Procedure: stress ui / pelvic organ prolapse.According to the reporter: an article titled "transischioanal trans-sacrospinous ligament rectocele repair with polypropylene mesh a prospective study with assessment of rectoanal function" that appeared in the internal urogynecology journal (2013) 24:81 - 89, states that a prospective multicenter study on 230 patient with stage ii-iv anterior and/or posterior pop who underwent rectocele repair via the infracoccygeal route through the sacrospinous ligament using ugytex.The current study is based on the analysis of the 116 patients.Seventy-eight patients were available for midterm anatomical results representing 67% (78/116) of the operated patients.The mean follow up was 36 (+/- 8.1) months.The objective success rate was 94.8% and subjective (patient satisfaction) was 93.23%.The 19 adverse events that were reported are rupture of lateral arm of the mesh; hematoma of pararectal fossa requiring surgery, unexplained fevers, transfusion, erosion without surgery, surgery for erosion, surgery for recurrence, surgery for de novo prolapse, and de novo dyspareunia.The complaints filed were only for the adverse events that directly correlate with the mesh being implanted.This complaint is for erosion.

Manufacturer Narrative

(b)(4).

• Brand Name: UGYTEX MESH PRODUCT
• Type of Device: UGYTEX MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3705247
• MDR Text Key: 4262941
• Report Number: 9615742-2014-00101
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2014

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 Catalogue Number: UNKNOWN UGYTEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other