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); Hernia (2240); 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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 recurrence, 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, medication, ct-scan, mesh removed, removal of drain, and admission to hospital.Relevant tests/laboratory data: 25 mar 2019: ct of pelvis showed large inflammatory mass present in anterior right pelvis consistent with an abscess surrounding the mesh, abscess extends into the abdominal musculature in at least 2 locations, minimal edema present in subcutaneous tissues anterior to abnormality 25 mar 2019: ultrasound of pelvis showed a 7.5x8.1 cm fluid collection surrounding the right inguinal mesh, most of it being superficial to the mesh ~01 apr 2019: anesthesia note stated bacteremia mssa 01 apr 2019: pathology report from infected right inguinal hernia mesh specimen showed benign sift tissue with acute and chronic inflammation with abscess with necrosis and granulation.Synthetic surgical mesh material.

• 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: justin ellis ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 11384973
• MDR Text Key: 233745599
• Report Number: 9615742-2021-00400
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180321
• UDI-Public: 10884521180321
• 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
• Report Date: 01/23/2023

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SRK0236X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2023
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 77 KG