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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 ventral incisional hernia.It was reported that after the implant, the patient experienced granuloma, draining sinus, draining wound, infection, foamy macrophages, focal foreign body-type giant cell reaction, necrosis, abscess, abundant foamy histiocytes and focal plasma cells, and wound dehiscence.Post-operative patient treatment included removal of mesh.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of ventral incisional hernia.It was reported that after the implant, the patient experienced granuloma, draining sinus, draining wound, infection, foamy macrophages, focal foreign body-type giant cell reaction, necrosis, abscess, abundant foamy histiocytes and focal plasma cells, recurrence, chronic pain and wound dehiscence.Post-operative patient treatment included removal of mesh, wound closure, suture removal and debridement.
 
Manufacturer Narrative
Additional information: b5, e1 (facility name, street 1, city, region, postal code, g1 (mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, 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.The product was used for laparoscopic therapeutic treatment of ventral incisional hernia.It was reported that after the implant, the patient experienced inflammation, adhesions, non-healing wound, skin ulceration, granuloma, draining sinus, draining wound, infection, foamy macrophages, focal foreign body-type giant cell reaction, necrosis, abscess, abundant foamy histiocytes and focal plasma cells, recurrence, chronic pain and wound dehiscence.Post-operative patient treatment included jp drain, penrose drain, skin resection, medication, mesh revision, removal of mesh, wound closure, suture removal and debridement.
 
Manufacturer Narrative
Additional info: b5, b7, g1, g3, h6 (added patient codes, ime e2402: "macrophages, abundant foamy histiocytes/focal plasma cells, sinus tract").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
UNKNOWN PARIETEX PRODUCT
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
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key10748436
MDR Text Key213452332
Report Number9615742-2020-02412
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN PROTACK (LOT#UNKNOWN); UNKNOWN PROTACK (LOT#UNKNOWN)
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient Weight119 KG
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