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

Model Number LPG1510X2

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: lpg1510x2 10x15 cm lp flatsheet mesh (lot# ppj1010x), lpg1510x2 10x15 cm lp flatsheet mesh (lot# ppj1010x).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 bilateral inguinal hernia by laparoscopic repair and an umbilical hernia by open repair.It was reported that after implant, the patient experienced chronic pain, abdominal pain, defective device, physical deformity, mental and physical pain, mesh failure, mental anguish, scarring, disfigurement, suffering, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included ilioinguinal neurectomy and revision surgery.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12923004
• MDR Text Key: 281655495
• Report Number: 9615742-2021-02444
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513143
• UDI-Public: 10884521513143
• Combination Product (y/n): N
• PMA/PMN Number: K120897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: LPG1510X2
• Device Catalogue Number: LPG1510X2
• Device Lot Number: PPJ1010X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Date Device Manufactured: 11/03/2015
• 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): Disability; Required Intervention
• Patient Age: 65 YR