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

Model Number TEM1515G

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

Patient Problems Abscess (1690); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 ventral incisional hernia. It was reported that after the implant, the patient experienced post operative incisional seroma, infected mesh, abscess, pain, lack of incorporation, scar, chronic inflammation (including plasma cells, lymphocytes, histocytes, multinucleated giant cells, eosinophils, rare neutrophils), non-healing wound, fibrosis, foreign body reaction, foreign body granuloma, draining sinus tract, and attenuated fascia. Post-operative patient treatment included wound debridement, incision and drainage, debridement down to fascial tissue, excision of infected hernia mesh, panniculectomy, removal of intraperitoneal and extraperitoneal infected hernia mesh, and repair of incisional hernia with phasix biologic mesh.

• 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: 9769222
• MDR Text Key: 181354284
• Report Number: 9615742-2020-00488
• Device Sequence Number: 1
• Product Code: FTL
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: TEM1515G
• Device Catalogue Number: TEM1515G
• Device Lot Number: SPI1165X
• 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: 04/08/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/14/2015
• 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: 02/28/2020 Patient Sequence Number: 1

Treatment

UNK PROTACK(LOT#: UNKNOWN)