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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 Cardiopulmonary Arrest (1765); Death (1802); Ischemia (1942); Pneumonia (2011); Hernia (2240); Bowel Perforation (2668); No Code Available (3191); Multiple Organ Failure (3261)
Event Date 04/22/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Title diaphragmatic herniation following esophagogastric resectional surgery: an increasing problem with minimally invasive techniques? source surg endosc (2016) 30:5419¿5427. Received: 20 january 2016 / accepted: 26 march 2016 / published online: 22 april 2016. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of a study of a prospective database of all resectional esophagogastric operations performed for cancer from (b)(6) 2001 to (b)(6) 2015, to describe and compare the incidence of post-operative diaphragmatic hernias (podh) over time and analyze the outcomes of patients who develop such a complication using a prospectively collected database of esophagogastric cancer resections from a single tertiary center, out of 631 patients who had hiatal dissection for malignancy, 35 patients developed of podh (5. 5 % overall incidence) following esophagogastric resectional surgery. 31 of these patients received surgery for these hernias. Out of the 31 patients, 5 patients received the composite mesh while the other patients received another manufacturer¿s mesh or had suture repair. Complications reported were the following: in-hospital post-operative mortality was 13% (n
=
4/31). All mortalities occurred in patients who required emergency surgery (n
=
4/20, 20 %). One of these patients died after colonic bowel ischemia and perforation caused fecal contamination of the left chest. Despite treatment with damage control surgery and intensive therapy unit (itu) support, the patient developed multi-organ failure and died. Two patients died of severe pneumonia and multi-organ failure after emergency repairs. Another patient died on intensive therapy unit (itu) after cardiorespiratory arrest.
 
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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 Key8824048
MDR Text Key152116555
Report Number9615742-2019-02656
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
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: 07/24/2019 Patient Sequence Number: 1
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