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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Perforation (2001); Seroma (2069); No Code Available (3191)
Event Date 02/01/2013
Event Type  Injury  
Manufacturer Narrative

Title laparoscopic tension-free abdominal wall repair: impact of mesh size and of different fixation devices in a consecutive series of 120 patients source surg laparosc endosc percutan tech, volume 24, 2014 (461-464) article number: 5 date of publication: 05 december 2012. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of a study performed between march 2005 to september 2011 regarding the impact of mesh size and fixation devices on short-term outcomes in a consecutive series of tension-free laparoscopic abdominal wall repairs, data for 120 consecutive, unselected patients undergoing tension-free laparoscopic incisional (n=63) or umbilical (n=57) hernia repair were prospectively collected. A double-layered mesh is sized to overlap the defect over at least 5 cm and is then rolled to protect the collagen layer and is introduced into the abdominal cavity. Four transparietal sutures are applied at the 4 corners of the mesh to suspend and precisely place the prosthesis below the defect. The mesh is fixed using titanium and absorbable tacks placed every 2 cm along the perimeter of the prosthesis it was stated that there were complications such as seromas (n=13), skin necrosis (n=1), port site bleeding (n=1), bladder perforation (n=1) and there were 2 recurrences from patients who received the mesh.

 
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Brand NamePARIETEX 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 Key8733219
MDR Text Key149153178
Report Number9615742-2019-02286
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
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 06/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
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 Received06/04/2019
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: 06/26/2019 Patient Sequence Number: 1
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