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

Model Number PPM1508X3

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scarring (2061); Tissue Damage (2104); Burning Sensation (2146); Hernia (2240); 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 a recurrent right inguinal hernia.It was reported that after implant, the patient experienced adhesions, chronic pain, severe chronic right groin and testicle pain, nerve damage, mesh contraction, recurrence.Previous incision too low causing trauma to underlyhing tissue, scarring, chronically enlarged and inflamed ilioinguinal nerve, iliohypogastric and genital-femoral nerves were entrapped in previous mesh with associated neuromas, no blood inflow or outflow to right testicle, and testicular artery entrapped with previously placed suture.Post-operative patient treatment included removal of testicle and revision surgery.

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 therapeutic treatment of a recurrent right inguinal hernia.It was reported that after implant, the patient experienced adhesions, chronic pain, severe chronic right groin and testicle pain, nerve damage, mesh contraction, recurrence.Previous incision too low causing trauma to underlying tissue, scarring, chronically enlarged and inflamed ilioinguinal nerve, iliohypogastric and genital-femoral nerves were entrapped in previous mesh with associated neuromas, no blood inflow or outflow to right testicle, and testicular artery entrapped with previously placed suture.Post-operative patient treatment included removal of testicle, revision surgery, neurectomy, mesh explant and additional implant for right inguinal hernia.

Manufacturer Narrative

Additional information.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 therapeutic treatment of a recurrent right inguinal hernia.It was reported that after implant, the patient experienced adhesions, chronic pain, severe chronic right groin and testicle pain, nerve damage, mesh contraction, recurrence, previous incision too low causing trauma to underlyhing tissue, scarring, chronically enlarged and inflamed ilioinguinal nerve, iliohypogastric and genital-femoral nerves were entrapped in previous mesh with associated neuromas, no blood inflow or outflow to right testicle, stabbing/burning pain, lack of energy/tired, and testicular artery entrapped with previously placed suture.Post-operative patient treatment included removal of testicle, revision surgery, ilioinguinal/iliohypogastric/genital-femoral neurectomies, triple neurectomy, injection of icg to test vascular flow to testicle, mesh explant, and hernia repair with new mesh.

• Brand Name: PARIETENE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9146974
• MDR Text Key: 161673172
• Report Number: 9615742-2019-03325
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521213814
• UDI-Public: 10884521213814
• Combination Product (y/n): N
• PMA/PMN Number: K142091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: PPM1508X3
• Device Catalogue Number: PPM1508X3
• Device Lot Number: SQF0070X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80