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

Model Number TECR1515

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

Patient Problems Adhesion(s) (1695); Cellulitis (1768); Edema (1820); Hematoma (1884); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: tecr1515 parietex rigid py 15x15cm x1 (lot# skf00630). (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 laparoscopic therapeutic treatment of a left inguinal hernia. It was reported that after the implant, the patient experienced recurrence, obliterated internal ring w/ balls of mesh embedded into the spermatic cord and pieces of mesh above the cord, hematoma, hydroceles, edema, cord lipoma, pain, scarring, wad of mesh, anatomy completely attenuated, swelling, tenderness, nausea, less frequent stools, and cellulitis. Post-operative patient treatment included revision surgery, removal of mesh, pain medication, orchiectomy, and hernia repair with new mesh.

• Brand Name: PARIETEX
• 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: 10253148
• MDR Text Key: 198186721
• Report Number: 9615742-2020-01507
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2015
• Device Model Number: TECR1515
• Device Catalogue Number: TECR1515
• Device Lot Number: SKH00177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• 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: 07/09/2020 Patient Sequence Number: 1