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

Model Number UNKNOWN URETEX TO

Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoconcentration (1288); Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Erosion (1750); Bradycardia (1751); Emotional Changes (1831); Fever (1858); Micturition Urgency (1871); Headache (1880); Incontinence (1928); Unspecified Infection (1930); Muscle Spasm(s) (1966); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Vomiting (2144); Weakness (2145); Hernia (2240); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Blood Loss (2597); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Fibrosis (3167); 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 of stress urinary incontinence.It was reported that after implant, the patient experienced abdominal/pelvic/bladder/vaginal pain, mesh erosion, mesh migration, mesh extrusion, infection, unspecified urinary problems, recurrence of stress urinary incontinence, dyspareunia, soreness, b ladder/pelvic organ/uterine prolapse, emesis, cystic endometrial atrophy, hernia, enterocele/cystocele/rectocele (prolapse), blood loss, adhesions, fibroid, spotting, bladder (muscle) spasms, hemorrhoids, mixed urinary incontinence with urge, voiding dysfunction, urgency, frequency, vaginal fullness/pressure, vaginal bulge/protrusion, vaginal discharge, headaches, incomplete bladder emptying, stool incontinence, unspecified emotional problems, bladder trabeculations, irritable bowel symptoms, bladder infections, decreased bladder capacity, low hematocrit/hemoglobin/red blood cells, high white blood cells, low blood pressure, anxiety, nausea, vomiting, elevated temperature, weakness, tenderness, drainage, urinary retention/obstruction, non-surgical and additional surgical interventions.

Manufacturer Narrative

(b)(4).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: 7782539
• MDR Text Key: 117127585
• Report Number: 9615742-2018-01887
• 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,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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 Model Number: UNKNOWN URETEX TO
• Device Catalogue Number: UNKNOWN URETEX TO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/14/2018
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 85