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

Model Number TECT1510AL

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Dehydration (1807); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Sepsis (2067); Electrolyte Imbalance (2196); Ascites (2596); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: tect1510ar anat rt std py 15x10cm (lot# sri0155x), abstack15 abs fixation device 15 tacks (lot# n8b0230mx). (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 bilateral inguinal hernia. It was reported that after implant, the patient experienced inflammatory mass consistent with an abscess, edema, fluid collection, bacteremia mssa, necrosis, granulation, bacteremia/sepsis, acute kidney injury, hyperkalemia, hypo natremia, dehydration, electrolyte abnormalities, induration, purulence, mesh free in abscess cavity, and infection. Post-operative patient treatment included revision surgery, antibiotics, iv fluids, drain placement, picc line, extended hospitalization, mesh removed, removal of drain, and admission to hospital.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11384973
• MDR Text Key: 233745599
• Report Number: 9615742-2021-00400
• 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

• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SRK0236X
• 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: 02/10/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/23/2017
• 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: 02/26/2021 Patient Sequence Number: 1