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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM2015
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Pulmonary Emphysema (1832); Fatigue (1849); Fever (1858); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Vomiting (2144); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Confusion/ Disorientation (2553); Ascites (2596); Abdominal Distention (2601); Constipation (3274); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 incisional hernia.It was reported that after implant, the patient experienced infected sinus tract and hernia recurrence due to failure of mesh.Post-operative patient treatment included additional surgery and mesh removal surgery.
 
Manufacturer Narrative
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 therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced defective mesh, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, injury, wound dehiscence, abdominal fluid collection, infected sinus tract, and hernia recurrence due to failure of mesh.Post-operative patient treatment included additional surgery, wound vac, mesh repair surgeries, and mesh removal surgery.
 
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Brand Name
SYMBOTEX
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
8200 coral sea st ne
mounds view,mn, CO 55112
7635265677
MDR Report Key12177963
MDR Text Key261907471
Report Number9615742-2021-01744
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190450
UDI-Public10884521190450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
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 07/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model NumberSYM2015
Device Catalogue NumberSYM2015
Device Lot NumberPPD0427X
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2023
Date Device Manufactured04/30/2015
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; Disability;
Patient Age75 YR
Patient SexFemale
Patient Weight89 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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