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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 TEC1515
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Gangrene (1873); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); 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.The product was used for therapeutic treatment of a bilateral inguinal hernia and umbilical hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, chronic drainage, abscess, colocutaneous fistula, and rectosigmoid inflammation.Post-operative patient treatment included bowel resection and mesh removal.
 
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: patient code-c64343(crohn's disease).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 bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, rectosigmoid inflammation, crohn¿s disease and ischemic, gangrenous, perforated splenic flexure.Post-operative patient treatment included bowel resection and removal of infected mesh, lysis of adhesions, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, and colon resection with ileocolotomy.
 
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.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 bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, and rectosigmoid inflammation.Post-operative patient treatment included bowel resection and removal of infected mesh, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, ileocolic resection, ileostomy and hartman's pouch.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, rectosigmoid inflammation, crohn¿s disease and ischemic, gangrenous, perforated splenic flexure, and pain.Post-operative patient treatment included bowel resection and removal of infected mesh, lysis of adhesions, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, and colon resection with ileocolotomy.
 
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.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key8396706
MDR Text Key138023744
Report Number9615742-2019-00408
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521180260
UDI-Public10884521180260
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2015
Device Model NumberTEC1515
Device Catalogue NumberTEC1515
Device Lot NumberSKL00388
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2021
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;
Patient SexMale
Patient Weight78 KG
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