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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Seroma (2069); Vomiting (2144); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); Unspecified Tissue Injury (4559)
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 hernia.It was reported that after implant, the patient experienced recurrence, adhesions and serosal tears.Post-operative patient treatment included excision 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 an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, serosal tears, abdominal pain, distention, vomiting, bulging of the abdominal wall, and deseasonalization.Post-operative patient treatment included mesh removal and small bowel resection.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions and serosal tears.Post-operative patient treatment included mesh removal and small bowel resection.
 
Manufacturer Narrative
Additional information: a4(weight in lbs), b5, b7,d7, g4.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 an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, serosal tears, abdominal pain, distention, vomiting, bulging of the abdominal wall, pain, inflammation, obstruction, fistula, seroma, perforation, focal mucosal erosion, necrosis, and deserosalization.Post-operative patient treatment included mesh removal and small bowel resection, abdominal wall reconstruction, wound vac, ct-scan, hernia repair with new mesh, cat scan, and medication.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, serosal tears, abdominal pain, distention, vomiting, bulging of the abdominal wall, pain, inflammation, obstruction, fistula, seroma, perforation, and deserosalization.Post-operative patient treatment included mesh removal and small bowel resection, abdominal wall reconstruction, wound vac, ct-scan, hernia repair with new mesh, and medication.Relevant tests/laboratory data: (b)(6) 2015: discharge summary states ct showed dilated small bowel loops with seroma formation in the abdominal wall.Second cat scan showed seroma formation above the mesh area.(b)(6) 2019: pathology report on explanted mesh and partial resection of bowel showed small bowel with focal mucosal erosion, necrosis, serosal fibrous adhesions.
 
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Brand Name
MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
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 Key8881876
MDR Text Key153947641
Report Number9615742-2019-02792
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179769
UDI-Public10884521179769
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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 05/01/2024
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 Date06/30/2019
Device Model NumberPCO2015X
Device Catalogue NumberPCO2015X
Device Lot NumberPOF0517X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/11/2019
Supplement Dates Manufacturer Received09/11/2019
09/11/2019
04/24/2024
05/01/2024
Supplement Dates FDA Received10/03/2019
10/10/2019
04/25/2024
05/01/2024
Date Device Manufactured07/05/2014
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 Age42 YR
Patient SexMale
Patient Weight100 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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