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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SYMBOTEX MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Event Date 06/26/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, the patient had surgery to correct an incisional hernia that was the result of a davinci robotic gallbladder removal surgery in 2016. The patient was informed that a hernia mesh would be used to repair the hernia and this was the only option that was given. The doctor used mesh and the hernia was repaired on 2018. From that time, the patient had recurrent stomach pain and in 2020 suffered a serious stomach episode at home which included severe pain with nausea and vomiting and diarrhea that lasted throughout the entire night but the patient treated at home. In 2020, the patient again had the same type of episode but on this occasion, went to the emergency room and was hospitalized for night and treated for a small bowel obstruction with a naso gastric tube and admission into the hospital for treatment. The patient had surgery in 2020 and found that the small bowel was twisted 180 degrees and adhered to the mesh. The surgeon cut the bowel away from my mesh, leaving the mesh adhered to the tissue for fear of damaging it and the patient was admitted to the hospital for 1 night for what supposed to be a day surgery due to the fact that the patient got fever and uncontrollable pain and low blood pressure. The issue with the mesh has caused the patient to miss multiple days from the job and pain/suffering as well as numerous medical expenses.

 
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Brand NameUNKNOWN SYMBOTEX MESH
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 Key11413969
MDR Text Key234728384
Report Number9615742-2021-00437
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,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN SYMBOTEX MESH
Device Catalogue NumberUNKNOWN SYMBOTEX MESH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated By Manufacturer? Yes
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: 03/04/2021 Patient Sequence Number: 1
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