MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS AVAULTA BIOSYNTHETIC SUPPORT SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN SOFRADIM MESH

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

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Disability (2371); Numbness (2415); Prolapse (2475); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: second unknown sofradim mesh, (lot # unknown).(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.It was reported that after the implant, the patient experienced pain, injury, suffering, impairment, back pain, pelvic pain, vaginal vault prolapse, foreign body in vagina, enterocele, stress urinary incontinence, ongoing bladder pain, chronic severe vaginal pain, chronic bladder discomfort, frequent urinary tract infections, significant pain during sexual intercourse, numbness in leg, and disability.Post-operative patient treatment required intervention to prevent permanent impairment/ damage.

• Brand Name: AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
• 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: 10163985
• MDR Text Key: 195444141
• Report Number: 9615742-2020-01312
• Device Sequence Number: 1
• Product Code: FTL
• 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: 06/17/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SOFRADIM MESH
• Device Catalogue Number: UNKNOWN SOFRADIM MESH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/17/2020
• 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