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

Model Number UNKNOWN PARIETENE MESH PRODUCT

Device Problem Degraded (1153)

Patient Problems Prolapse (2475); Urinary Incontinence (4572)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Title: modified laparoscopic lateral suspension with a fve-arm mesh in pelvic organ prolapse surgery source: akbaba and sezgin bmc women¿s health (2021) 21:244.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between march 2016 and january 2020, out of the 37 study patients who underwent laparoscopic lateral suspension procedure for advanced stage pelvic organ prolapse, postoperative recurrence - vaginal mesh erosion (1), recurrence - anterior compartment (2) and stress urinary incontinence (7) were reported. patients who had recurrence had reoperation.

• Brand Name: UNKNOWN PARIETENE MESH PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13339223
• MDR Text Key: 284349422
• Report Number: 9615742-2022-00071
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETENE MESH PRODUCT
• Device Catalogue Number: UNKNOWN PARIETENE MESH PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• 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 Sex: Female