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

Model Number UNKNOWN PROGRIP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Purulent Discharge (1812); Internal Organ Perforation (1987); Pain (1994); Swelling (2091); Hernia (2240); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent the repair of right inguinal hernia repair with mesh, anterior approach.The patient experienced surgical revision, pain, organ perforation and recurrence.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 right inguinal hernia repair with mesh, anterior approach.It was reported that after the implant, the patient experienced organ perforation, recurrence, swelling, purulent drainage, cysts, and redness.Post-operative patient treatment included revision surgery, groin exploration with washout of wound infection, removal of mesh, and wound vac.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 right inguinal hernia repair with mesh, anterior approach.The patient experienced pain, organ perforation and recurrence.Post-operative patient treatment included revision surgery.

• 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: 7029426
• MDR Text Key: 91952620
• Report Number: 9615742-2017-05717
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2020

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: UNKNOWN PROGRIP
• Device Catalogue Number: UNKNOWN PROGRIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 05/22/2019; 05/22/2019
• Supplement Dates FDA Received: 12/17/2019; 02/10/2020
• 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): Other; Required Intervention