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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH

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SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH Back to Search Results
Model Number UNKNOWN SYMBOTEX MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 05/05/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: mesh-related complication rates of two different mesh types on umbilical/ventral hernia repair source saudi j. Med. Pharm. Sci, volume 4, 2018 (539-541). Article number: 5 date of publication: 30 may 2018. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source study performed in two groups of patients (group 1: composite mesh, group 2: dual-sided mesh), three cases of wound infection occurred, and 1 patient developed seroma in group 1. One patient required reoperation and mesh removal with a subsequent development of hernia in group 1. The other patients were treated with enteral antibiotics, and no further intervention was necessary. No other major complications occurred in the immediate postoperative period.

 
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Brand NameUNKNOWN SYMBOTEX MESH
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 Key9519772
MDR Text Key172734284
Report Number9615742-2019-03914
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2019
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 Received12/12/2019
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: 12/26/2019 Patient Sequence Number: 1
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