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

Model Number UNKNOWN URETEX MESH PRODUCT

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

Patient Problems Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fever (1858); Fistula (1862); Incontinence (1928); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 of large cystocele, vaginal cuff prolapse as well as rectocele and stress incontinence.It was reported that after implant, the patient experienced urinary frequency, urinary incontinence, uti's, burning on urination, lower backache, stress, obstructing cystocele, vaginal bleeding, scarring, discomfort, tight vaginal cuff, vaginal atrophy, dysuria, pelvic pain, bladder spasms, fevers, abnormal smelling urine, acute cystitis, fistula, bladder/kidney stone, erosion to anterior vaginal wall, and exposed mesh.Post-operative patient treatment included vaginoscopy, cystoscopy (also underwent right ureteral stent placement), excision of mesh and placement of mesh.

• 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: 8899616
• MDR Text Key: 154537424
• Report Number: 9615742-2019-02840
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/15/2019

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 Model Number: UNKNOWN URETEX MESH PRODUCT
• Device Catalogue Number: UNKNOWN URETEX MESH PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• 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): Required Intervention
• Patient Weight: 68