MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN IVS TUNNELLER DEVICE

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

Patient Problems Hemorrhage/Bleeding (1888); Prolapse (2475)

Event Date 08/10/2021

Event Type  Injury  

Event Description

According to literature source of study performed between 2010 and 2020, of the seven hundred forty six patients who underwent surgical procedure for pelvic organ prolapse.  thirty seven patients who underwent mesh augmented repair, the device was used in seventeen patients.  postoperative complications included: prolapse recurrence, three patients experienced hemorrhage, three patients experien ced vaginal mesh exposure. In one case the patient was asymptomatic and treated with topic estrogen.  in the other two cases, the exposure was associated with vaginal discharge and required partial mesh removal in the operation room to treat prolapse recurrence. Three patients did physiotherapy, five were eligible for pessary placement.  twenty eight women underwent native tissue repair surgery, of which twelve were submitted to anterior colporraphy, nine to posterior colporraphy, nine underwent an obliterative procedure - colpocleisis, six sacrospinous ligament fixation and three vaginal hysterectomy.  other complications that were not related to the device included: urinary tract infection to seventeen patients, postoperative fever to eleven patients and vaginal cuff hematoma to three patients. One patient died due to unrelated causes.

Manufacturer Narrative

Title: pelvic organ prolapse repair-relapse risk factors: a 10-year retrospective study source: https://doi. Org/10. 1016/j. Gine. 2021. 100712 0210-573x/© 2021 elsevier espana, ¿ s. L. U. All rights reserved. If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN IVS TUNNELLER DEVICE
• 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: 13009556
• MDR Text Key: 282262831
• Report Number: 9615742-2021-02485
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN IVS TUNNELLER DEVICE
• Device Catalogue Number: UNKNOWN IVS TUNNELLER DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/15/2021 Patient Sequence Number: 1