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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Arteriosclerosis (1722); Atrial Fibrillation (1729); Bacterial Infection (1735); Death (1802); Diarrhea (1811); Dyspnea (1816); Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pleural Effusion (2010); Renal Failure (2041); Sepsis (2067); Vomiting (2144); Weakness (2145); Discharge (2225); Hernia (2240); Discomfort (2330); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Ascites (2596); Blood Loss (2597); No Code Available (3191); Constipation (3274)
Event Type  Death  
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 multiple ventral hernias. It was reported that after implant, the patient experienced infection, severe abdominal pain, diarrhea, tolerating little food and not walking, vomiting, suffered fall due to weakness, shortness of breath, gi infection, watery, bloody stools, mid abdominal mass markedly tender to palpation, coumadin toxicity, sepsis and abdominal wall abscess, atrial fibrillation, hypotension, lactatemia and leukocytosis, splenomegaly, subscapular fluid collection, gi hemorrhage, colonic fistula, c diff colitis, leukocytosis, lactic acidosis, acute renal failure, anemia due to blood loss, severe sepsis with acute organ dysfunction, severe protein calorie malnutrition, gram neg infection, pseudomonas infection, constipation, nausea when sees food, increase drainage from wound. Post-operative patient treatment included iv fluids and blood transfusion (2 units), incision and drainage of abdominal wall abscess, hospital stay, skilled level care, long term care facility, and patient passed away on (b)(6) 2017. Death certificate notes cause of death as abdominal wall abscess, colonic fistula and diverticulosis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYMBOTEX
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8998238
MDR Text Key157688409
Report Number9615742-2019-03086
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberSYM2015
Device Catalogue NumberSYM2015
Device Lot NumberPOL0671X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/07/2015
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: 09/11/2019 Patient Sequence Number: 1
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