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

Model Number TEM1208GL

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

Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the survey source, after using the mesh, there were patients experienced the following complications: 10 patients with chronic pain (developed chronic pain which did not resolve with standard treatment and required referral to pain specialist), 2 patients with mesh infection (unusual to have mesh infection in modern hernia practice that the wound had to be left open with antibiotics before symptoms settled), 5 patients with seroma/hematoma (expected complication which was settled on conservative treatment), 4 patients with infection (treated with antibiotics and drainage where appropriate), and 1 patient with genital complication (which required removing testicle, was a recurrent hernia).

• 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: 8946740
• MDR Text Key: 156039646
• Report Number: 9615742-2019-02913
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177697
• UDI-Public: 10884521177697
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• 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): Required Intervention