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

Model Number TEM1509G

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Chills (2191); Hernia (2240); Injury (2348); Numbness (2415); Weight Changes (2607); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 recurrent incisional hernia. It was reported that after implant, the patient experienced nausea, chills, inflammation, weight gain, numbness, adhesions, infections, scarring, fistula, severe pain, tearing sensation in the abdomen, periodic purulent draining from c-section scar, wadded piece of mesh with fistula tract up to skin, second piece of unincorporated mesh at symphysis pubis, and abdominal wall seroma. Post-operative patient treatment included revision surgery. The plaintiff has ongoing medical issues including the need for future medical treatment.

• 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, CT 80301 ; 3035816943
• MDR Report Key: 8716357
• MDR Text Key: 148549488
• Report Number: 9615742-2019-02269
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TEM1509G
• Device Catalogue Number: TEM1509G
• Device Lot Number: LOG220145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 06/20/2019 Patient Sequence Number: 1