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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 Arrhythmia (1721); Seroma (2069); Post Operative Wound Infection (2446); Prolapse (2475); No Code Available (3191)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative

Title robotic-assisted ventral hernia repair with surgical mesh: how i do it and case series of early experience source anz j surg, 2019 (1-7) date of publication: 11 december 2018. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of the study performed from may 2015 to august 2018, 50 patients underwent robotic assisted ventral hernia repair post -operative a procedure, out of 50 patients, 2 patients had a recurrence with a extended hospital stay of 3 days, 2 had a minor wound infection, 1 had aspiration pneumonia, 1 had ileus arrhythmias, 1 had ileus and seroma, and 1 had arrhythmia and abdominal wall hematoma.

 
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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 Key8573204
MDR Text Key143822240
Report Number9615742-2019-01568
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 05/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 05/02/2019 Patient Sequence Number: 1
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