MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number URETEXTO3

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Injury (2348); No Code Available (3191)

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.The patient underwent mesh implantation of transvaginal mesh for urinary stress incontinence.The postoperative complications that this patient developed following transvaginal placement of surgical mesh in 2008 ¿ patient underwent transobturator tape (uretex to3) procedure under general anesthesia.The cystoscopy revealed gross hematuria emanating from the right ureteral orifice.As a consequence, the anterior vaginal wall repair was undone by cutting the suture.The transobturator tape was removed.Complications post uretex to3 placement in 2009 ¿ urinary stress incontinence and now returns for replacement of trans obturator tape (tot), gross hematuria, urinary tract infection (uti) - plan to transobturator tape procedure and removal of right ureteral stent.Patient underwent additional implant (uretex to3) surgery in 2009 with transobturtor tape (uretex to3) placement for urinary stress incontinence under general anesthesia.Complications post additional implant surgery:2009 - admitted for left renal extracorporeal shock wave lithotripsy (eswl) for a left renal calculus that measures 7 x 3 mm in the inferior callax of the left kidney.- left renal calculus.Plan to proceed left renal eswl.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - URETEX
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 7715682
• MDR Text Key: 114884762
• Report Number: 9615742-2018-01715
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041176
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: URETEXTO3
• Device Catalogue Number: URETEXTO3
• Device Lot Number: SGA00686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 02/01/2006
• 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