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

Model Number URETEXSUP

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

Patient Problems Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Hematuria (2558); Blood Loss (2597); No Code Available (3191); Constipation (3274)

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.The product was used for therapeutic treatment.It was reported that after implant, the patient experienced cystitis, pain with sexual activity, urinary tract infection, recurrent stress incontinence, vaginal discomfort, weak urine stream, sensation of incomplete emptying, heavy incontinence, vaginal tenderness, urethral hypomobility, failed kegel exercises/pelvic floor exercises, reduced bladder contractility, occasional urgency, micro-hematuria, nephrolithiasis, lithotripsy with stent placement, intermittent right flank pain, bleeding, calcification/left renal stone, persistent elevated creatinine level, vaginal scarring, bladder instability, mixed urinary incontinence, urgency of urination, dyspareunia, recurrent stress incontinence, and vaginal tenderness not just over sling area but also laterally and posteriorly, urethral hypomobility, and placement of gynecare tvt-o, drainage, mental and physical stress, vaginal vault damage, scar tissue, chronic constipation, irritable bowel syndrome, recurrent vaginal or bladder infections.The patient required a surgical and multiple non-surgical intervention.Complications post (uretex sup) implantation: on 2011: had recurring stress incontinence, pain with intercourse, weak urine stream, urinary tract infection (uti), sensation of incomplete emptying.On exam vaginal tenderness not just over sling area but also laterally and posteriorly.Urodynamics showed residual volume 100 cc prior to uds, 120 cc after uds, at 150 cc no sui, at 300 cc, stress incontinence with cough was + noted at 300 ml.Ordered for urine culture (b)(6) 2011: had stress urinary incontinence.Scheduled for placement of midurethral tvt-o gynecare tension-free taping for stress incontinence and cystoscopy.Additional mesh implant (using gynecare tvt-o) surgery: (b)(6) 2011: underwent placement of mid-urethral tvt-o gynecare tension-free taping for stress incontinence and cystoscopy for urethral hypermobility, stress urinary incontinence in a female under general anesthesia.On 2012: complications post additional mesh- implant and corresponding interventions: on exam noticed a tear along the edge of her right labia.Had intercourse and that hurts, probably from this tear.Urinalysis showed trace amount of blood.On 2013: had left sided flank pain.Assessed with 7 mm left renal stone on renal ultrasound.Scheduled for cystoscopy, left ureteroscopy, laser lithotripsy, stone extraction, retrograde pyelogram, ureteral stent placement.Additional surgery details: (b)(6) 2013: underwent cystoscopy, left ureteroscopy, laser lithotripsy, stone extraction, retrograde pyelogram, and ureteral stent placement for left renal stone under general anesthesia.On 2014: had microhematuria on urinalysis, intermittent bothersome right flank pain for the past month.

• 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: 8696206
• MDR Text Key: 147913924
• Report Number: 9615742-2019-02184
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

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: URETEXSUP
• Device Catalogue Number: URETEXSUP
• Device Lot Number: SGB00409
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/13/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 64