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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS 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 Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: preliminary results about a novel technique of mesh positioning in the abdominal wall hernia repair source: g chir vol. 39 - n. 4 - pp. 223-226. Date published: july-august 2018. If information is provided in the future, a supplemental report will be issued. [(b)(4)].

 
Event Description

According to the literature study, it showed the results of a different mesh positioning technique in the intraperitoneal onlay mesh mediated abdominal wall hernia repair using dual-mesh prosthesis defined ¿percutaneous technique positioning¿ instead of the classic positioning technique. For all surgical operation, a three-dimensional (3d) textile monofilament polyester (pet) mesh with bioabsorbable collagen film was used. Fixation device was also used. There were 18 postoperative complications which includes wound infection (5), hematoma (5), seroma (7) and recurrence (1).

 
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Brand NameSYMBOTEX 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 Key8495982
MDR Text Key141350113
Report Number9615742-2019-01128
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 04/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2019
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: 04/09/2019 Patient Sequence Number: 1
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