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

Model Number UNKNOWN MESH

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348); No Code Available (3191)

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 a hernia.It was reported that after a procedure where this device was implanted, the patient experienced an unspecified adverse outcome.

Manufacturer Narrative

Updated with newly received information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This event is a duplicate of report# 9615742-2018-01791.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNK 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: 7752178
• MDR Text Key: 116081698
• Report Number: 9615742-2018-01796
• 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,Followup,Followup,Followup
• Report Date: 10/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MESH
• Device Catalogue Number: UNKNOWN MESH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018; 10/03/2018
• Supplement Dates FDA Received: 08/21/2018; 10/04/2018; 10/31/2018
• 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 Weight: 81