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

Model Number TEM1509G

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

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

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 preoperative and postoperative diagnosis was recurrent umbilical hernia.The procedure performed was a repair of umbilical hernia with mesh onlay.The patient has had a surgical revision, chronic pain 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 an umbilical hernia.It was reported that after onlay implant, the patient experienced chronic pain, dysuria, scar tissue, adhesions and recurrence.Post-operative patient treatment included repair of umbilical hernia, exploration of umbilical hernia repair site with debridement of scar tissue.

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 an umbilical hernia.It was reported that after implant, the patient experienced chronic pain, scar tissue, adhesions and recurrence.Post-operative patient treatment included repair of umbilical hernia, exploration of umbilical hernia repair site with debridement of scar tissue.

• Brand Name: PROGRIP
• 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: 6914074
• MDR Text Key: 88159557
• Report Number: 9615742-2017-05379
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177673
• UDI-Public: 10884521177673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

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 Expiration Date: 06/30/2013
• Device Model Number: TEM1509G
• Device Catalogue Number: TEM1509G
• Device Lot Number: SIG00471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 05/15/2015; 05/15/2019
• Supplement Dates FDA Received: 10/09/2019; 11/06/2019
• 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 Age: 26 YR
• Patient Weight: 83