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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1208GR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Scarring (2061); Swelling (2091); Chills (2191); Hernia (2240); Injury (2348); Weight Changes (2607); No Code Available (3191); Constipation (3274)
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 therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced severe pain, extensive scarring, nerve damage, hematoma, nausea, inflammation, chills, constipation, weight loss, loss of appetite, recurrence, swelling and large clot within groin.Post-operative patient treatment included revision surgery.The plaintiff has ongoing medical issues including the need for future medical treatment.
 
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 a right inguinal hernia.It was reported that after implant, the patient experienced severe pain, extensive scarring, nerve damage, hematoma, nausea, inflammation, chills, constipation, weight loss, loss of appetite, recurrence, swelling and large clot within groin.Post-operative patient treatment included revision surgery, mesh explant and additional implant.The plaintiff has ongoing medical issues including the need for future medical treatment.
 
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Brand Name
MESH SOFRADIM - PARIETEX¿ PROGRIP¿
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key8765000
MDR Text Key150162651
Report Number9615742-2019-02409
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177697
UDI-Public10884521177697
Combination Product (y/n)N
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSSD0066X
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight66
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