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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 PCO12X
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Emotional Changes (1831); Fatigue (1849); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Dizziness (2194); Injury (2348); Impaired Healing (2378); Diaphoresis (2452); Ascites (2596); Blood Loss (2597); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 hernia repair with mesh. The patient had revision surgery 2 months post-surgery. The patient experienced infection, chronic pain, and wound treatment.
 
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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after the implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, infection with green mucus drainage, chronic pain, seroma, intramuscular hematoma, moderate enterococcus faecalis and light staphylococcus aureus, swelling, dizziness, abdominal pain, diarrhea, blood loss, nausea, cold sweats, purulent material, fatigue, abscess, necrotic tissue, granulation tissue, fluid collection, open wound, and wound dehiscence. Post-operative patient treatment included revision surgery, antibiotics, debridement of wound, wound vac, and admission to hospital.
 
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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after the implant, the patient experienced infection with green mucus drainage, chronic pain, seroma, intramuscular hematoma, moderate enterococcus faecalis and light staphylococcus aureus, swelling, dizziness, abdominal pain, diarrhea, blood loss, nausea, cold sweats, purulent material, fatigue, abscess, necrotic tissue, granulation tissue, fluid collection, open wound, and wound dehiscence. Post-operative patient treatment included revision surgery, antibiotics, debridement of wound, wound vac, and admission to hospital.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of an incisional hernia. It was reported that after the implant, the patient experienced infection, chronic pain, seroma, intramuscular hematoma, moderate enterococcus faecalis and light staphylococcus aureus, swelling, dizziness, abdominal pain, diarrhea, blood loss, nausea, cold sweats, purulent material. Fatigue, abscess, necrotic tissue, granulation tissue, and fluid collection. Post-operative patient treatment included revision surgery, antibiotics, debridement of wound, wound vac, and admission to hospital.
 
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.
 
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 NamePARIETEX
Type of DeviceMESH, 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 80301
3035816943
MDR Report Key7362209
MDR Text Key103190422
Report Number9615742-2018-00579
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179745
UDI-Public10884521179745
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 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberPCO12X
Device Catalogue NumberPCO12X
Device Lot NumberPPB0777X
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2018 Patient Sequence Number: 1
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