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

Model Number UNKPARUGYTEX

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint number: (b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The reason for mesh implantation was pelvic organ prolapse and cystocele.The procedure performed was placement of mesh.The patient experienced ¿ronic pelvic pain, vaginal area pain, dyspareunia, frequency/ urgency, vaginal infection, abdominal inflammation, mesh erosion, severe vaginal bleeding.In (b)(6) 2008 the patient underwent mesh removal for severe vaginal bleeding.The patient suffered injuries including infections, pain, mental anguish, discharge, and multiple corrective surgeries.

• Brand Name: 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: sharon ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6697973
• MDR Text Key: 79531808
• Report Number: 9615742-2017-05181
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 10/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKPARUGYTEX
• Device Catalogue Number: UNKPARUGYTEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2012
• 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: 59 YR