MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN SOFRADIM MESH; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN SOFRADIM

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

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Abdominal Cramps (2543); 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.Product was used for therapeutic treatment.The reason for mesh implantation: symptomatic pelvic organ prolapse and genitourinary stress incontinence.The procedure performed: total vaginal hysterectomy, vaginal and perivaginal repair with avaulta graft, vaginal tape sling with uretex graft, diagnostic cystoscopy, enterocele repair with avaulta graft, rectocele repair with avaulta graft, perineoplasty and vaginal vault suspension.Findings: symptomatic uterine prolapse, symptomatic cystocele, large enterocele, symptomatic rectocele and enlarged genital hiatus.There was significant third-degree uterine prolapse, there was a fourth-degree cystocele, third-degree enterocele and third-degree rectocele.There was also enlarged genital hiatus.Complications post avaulta and uretex implantation: (b)(6) 2006-(b)(6) 2008 patient had complications like cramps across lower abdomen, knot in vaginal area causing dyspareunia, urinary frequency, narrowed vagina, vaginal discharge, underwent an in-office granulation tissue cauterization on (b)(6) 2007, recurrence of prolapse, grade ii cystocele, rectocele, mesh erosion at the vaginal apex - planned for cystocele repair with graft and will remove the mesh and perform cystoscopy on (b)(6) 2008.

• Brand Name: UNKNOWN SOFRADIM MESH
• 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: 7663945
• MDR Text Key: 113228532
• Report Number: 9615742-2018-01459
• 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: Other
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SOFRADIM
• Device Catalogue Number: UNKNOWN SOFRADIM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2013
• 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
• Patient Age: 66 YR