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

Model Number TECT1510AL

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Renal Failure (2041); Scar Tissue (2060); Scarring (2061); Urinary Retention (2119); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre- and post-op diagnosis: unavailable- no op-report.The procedure performed was the patient underwent laparoscopic, bilateral inguinal hernia.Other relevant history: claimant has had a surgical revision including removal of mesh; bilateral recurrent inguinal hernias; chronic abdominal pain; bowel/bladder perforation; chronic abdominal pain.Concomitant therapy: autosuture, lot#n1c0633ux, ref#abstacl15; autosuture, lot#n1c0633ux.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.(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.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced recurrence, chronic abdominal pain, bowel/bladder perforation, inflammation, scarring, high creatinine, urinary retention, renal failure requiring hospitalization, inguinal discomfort, pain and burning, adhesions, and scarring.Post-operative patient treatment included drainage of bladder, lap bilateral inguinal herniorrhaphy, open bilateral recurrent incarcerated inguinal hernia repair bard perfix large plug & onlay patch (left & right).

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced recurrence, chronic abdominal pain, bowel/bladder perforation, inflammation, and scarring.Post-operative patient treatment included revision surgery and removal of mesh.Concomitant therapy: autosuture, lot#n1c0633ux, ref#abstacl15; autosuture, lot#n1c0633ux.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced mental pain, pain/suffering, device defective, mesh failure, disability, impairment, loss of enjoyment of life, hernia recurrence, bowel/bladder perforation, inflammation, scarring, high creatinine, urinary retention, renal failure requiring hospitalization, inguinal discomfort, burning, adhesions, and abdominal pain.Post-operative patient treatment included drainage of bladder, lap bilateral inguinal herniorrhaphy, open bilateral recurrent incarcerated inguinal hernia repair bard prefix large plug & onlay patch (left & right), and mesh removal.

Manufacturer Narrative

H6 patient codes - c64343 (high creatinine) 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.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.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6887292
• MDR Text Key: 87196492
• Report Number: 9615742-2017-05344
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180321
• UDI-Public: 10884521180321
• Combination Product (y/n): N
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SKK00052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSTACK15(LOT#: N1C0633UX); TECT1510AR ANAT RT STD PY 15X10CM (LOT#:SKK00234); TECT1510AR LOT NUMBER: SKK00234
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 72 YR
• Patient Weight: 77