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

Model Number LPG1510AR

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: baxter bioscience, surgiflo hemostatic sealant, lot# 160541, exp. Date: (b)(6) 2017. 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. It was reported that after implant, the patient experienced hernia recurrence, mesh shrinkage, mesh migration, nerve damage, pain, and suffering. Post-operative patient treatment included 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11787628
• MDR Text Key: 249447023
• Report Number: 9615742-2021-00980
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2019
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: RQD0662X
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/06/2021 Patient Sequence Number: 1