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

Model Number 482412

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

Patient Problems Injury (2348); Prolapse (2475)

Event Date 07/31/2003

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 cystocele.It was reported that after the implant, the patient experienced recurrence.Post-operative patient treatment included revision surgery, abdominal sacrocolpopexy, abdominal paravaginal repair, cystourethroscopy, and recurrence repair with new mesh.

• Brand Name: PELVICOL
• 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: 10083044
• MDR Text Key: 191833819
• Report Number: 9615742-2020-01167
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2005
• Device Model Number: 482412
• Device Catalogue Number: 482412
• Device Lot Number: 03802B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• 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 Age: 52 YR