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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Skin Discoloration (2074); Prolapse (2475); No Code Available (3191)
Event Date 05/01/2012
Event Type  Injury  
Manufacturer Narrative

Title: laparoscopic incisional and ventral hernia repair (livhr) with parietex composite mesh. Source: minimally invasive therapy volume 21, 2012 (173¿180). (b)(4). If information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to the literature study performed between january 2007 and november 2010 87 patients were admitted with the diagnosis of abdominal wall hernia and underwent laparoscopic incisional and ventral hernia repair. The mesh was anchored to the abdominal wall and fixed with circumferential application tack appliers. There was an intra-operative complication in which 1 patient had a bleeding of the abdominal wall. Early postoperative complications for 6 patients include seroma, trocar site infection and abdominal wall ecchymosis. Late postoperative complication which was observed at follow up for 8 patients were 6 had seroma 1 had persistent hematoma and 1 had persistent abdominal pain. 3 patients had open repair conversion due to 2 of them had multiple endoabdominal adhesions and 1 had uterine fibromyomatosis. 2 patient had hernia recurrence.

 
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Brand NameUNKNOWN PARIETEX
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 Key8801041
MDR Text Key151417354
Report Number9615742-2019-02589
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,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
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? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
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: 07/17/2019 Patient Sequence Number: 1
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