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

Model Number UGYKP

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

Patient Problems Failure of Implant (1924); Hernia (2240); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Occupation : attorney (atty).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 adverse outcome.Product was used for therapeutic treatment.Patient underwent mesh implantation for cystocele with paravaginal defect, rectocele.In 2007 patient underwent placement of avaulta anterior and posterior mesh.First additional mesh implant surgery in 2008 patient underwent laparoscopy, adhesiolysis and sacrocolpopexy with biologic mesh (pelvisoft) for apical wall prolapse under general anesthesia.Mesh revision along with second additional mesh implant surgery in 2009: underwent revision of vaginal mesh, anterior colporrhaphy with vaginal vault suspension using, elevate intepro lite mesh, posterior elevate intepro lite mesh, miniarc suburethral sling, cystoscopy, enterocele repair for recurrent pelvic prolapse, vaginal vault prolapse, cystocele, rectocele, stress urinary incontinence under general anesthesia.

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: 7715627
• MDR Text Key: 114883294
• Report Number: 9615742-2018-01717
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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