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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a right hernia repair with mesh.He had revision surgery 5 months post-surgery.The patient experienced surgical revision, infection.
 
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.Product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, light growth (b)(6), recurrence, testicular pain, pus, inflammation, mass and adhesions.Post-operative patient treatment included revision surgery and reconstruction of left inguinal canal without mesh.
 
Event Description
The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, recurrence, and adhesions.Post-operative patient treatment included revision surgery and reconstruction of left inguinal canal without mesh.
 
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.Additional information: a4, b2(removed other), b5, d7, e1(facility name, street 1, city, region, postal code, phone#), e3, e4(email), g4, h6 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.Product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, light growth staphylococcus aureus, recurrence, testicular pain, pus and adhesions.Post-operative patient treatment included revision surgery and reconstruction of left inguinal canal without mesh.
 
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.Additional information: h6: patient code-c64343 (mass).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.
 
Manufacturer Narrative
Additional information: (patient codes), additional codes.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.Product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, light growth staphylococcus aureus, recurrence, testicular pain, pus, inflammation, mass, obstruction, pain, and adhesions.Post-operative patient treatment included ct-scan, mesh removal, medication, revision surgery and reconstruction of left inguinal canal without mesh.Relevant tests/laboratory data: 13 oct 2017: op note- ct scan worrisome for mesh infection.(b)(6) 2017: microbiology- light growth staphylococcus aureus.
 
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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 Key7400076
MDR Text Key104527904
Report Number9615742-2018-00779
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521180284
UDI-Public10884521180284
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model NumberTECR1510
Device Catalogue NumberTECR1510
Device Lot NumberSQI1145X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/07/2018
Initial Date FDA Received04/05/2018
Supplement Dates Manufacturer Received05/15/2019
05/15/2019
01/22/2020
11/08/2023
Supplement Dates FDA Received10/30/2019
01/16/2020
01/31/2020
11/14/2023
Date Device Manufactured10/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age57 YR
Patient SexMale
Patient Weight98 KG
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