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

Model Number UGYKA

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.Additional information has been requested, but not yet received.Per additional information received, the patient has experienced blood loss, complete vaginal vault/cuff prolapse, adhesions, lump in vagina, tenderness, cystocele/rectocele/enterocele (prolapse), posterior vaginal wall protrusion at the level of the vaginal introitus, stress urinary incontinence, mesh material detached from most of vagina, mesh exposure, vaginal defect, rectal bleeding, pain, dyspareunia, vault relaxed, partial prolapse, cystorectocele, tenderness, abnormal discharge, redundant rectovaginal herniation (rectocele), menopause, closed vaginal cuff, mesh eroding (erosion), and additional surgical 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: 7642946
• MDR Text Key: 112499481
• Report Number: 9615742-2018-01384
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: PHH00250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• 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: 49 YR