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

Model Number TEM1208GL

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Edema (1820); Granuloma (1876); Nerve Damage (1979); Pain (1994); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 an inguinal hernia. It was reported that after implant, the patient experienced recurrence, nerve damage, dense adheisons, spermatic cord displaced by scarring, scarification of the tissues, shrinkage of mesh, disengagement of mesh, blood supply exceptionally diminished to left testicle and spermatic cord, granulomas, edematous, lack of incorporation, tenderness, pain, and scar encasement. Post-operative patient treatment included revision surgery, hernia repair with new mesh, doppler confirmation of the blood supply of the left testicle and spermatic cord, right genitofemoral neurectomy/neuroplasty, right ilioinguinal neurectomy/neuroplasty, right iliohypogastric neurectomy/neuroplasty, removal of mesh granulomas with multiple foreign bodies, removal of suture, and mesh removal.

• 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: 10462925
• MDR Text Key: 204689291
• Report Number: 9615742-2020-01906
• 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
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2018
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SNC0678
• 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: 08/12/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/12/2013
• 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: 08/27/2020 Patient Sequence Number: 1