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

Model Number TECGK03

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, there was mesh erosion into the vagina.Surgery was performed to recover the mesh and to cover the areas that were overexposed.

• Brand Name: PROSUP
• 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: 11085928
• MDR Text Key: 224035752
• Report Number: 9615742-2020-02933
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982532
• 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
• Report Date: 12/29/2020

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: TECGK03
• Device Catalogue Number: TECGK03
• Device Lot Number: SLB00220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• 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