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

Model Number UNKNOWN PARIETEX PRODUCT

Device Problems Material Erosion (1214); Unintended Movement (3026)

Patient Problems Erosion (1750); Tissue Damage (2104); Tissue Damage (2104); No Code Available (3191)

Event Date 12/07/2011

Event Type  Injury  

Manufacturer Narrative

Occupation: na/other.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic ventral mesh rectopexy, mesh subsequently eroded into the back of the wall of the vagina.The patient was required further surgery to remove the mesh and repair the vagina.

Manufacturer Narrative

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

Manufacturer Narrative

Occupation: na/other.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic ventral mesh rectopexy, mesh subsequently eroded into the back of the wall of the vagina.The patient was required further surgery to remove the mesh and repair the vagina.

• Brand Name: PARIETEX
• 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: 7756505
• MDR Text Key: 116224759
• Report Number: 9615742-2018-01815
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention