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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Dysphagia/ Odynophagia (1815); Internal Organ Perforation (1987); Hernia (2240); Laceration(s) of Esophagus (2398); No Code Available (3191)
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative
Title: subjective outcome after laparoscopic hiatal hernia repair for intrathoracic stomach source langenbecks arch surg (2017) 402:521¿530. Date of publication: 9 november 2016. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the study, postoperative intra thoracic stomach hiatal hernia repair procedure, between january 2004 and january 2015, eighty-six patients underwent laparoscopic repair for intra thoracic stomach, from which, one patient died during surgery. Upon medical review; the event of a patient death and its reported severity is not related to the device or therapy because a perforation of the aorta occurred intraoperatively during mobilization of the esophagus, and the damage to the aorta was too extensive and the patient died during surgery. An autopsy revealed an aneurysm, which was unknown prior to surgery. The patient's death is not device related.
 
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Brand NameUNKNOWN PARIETEX PRODUCT
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 Key9578489
MDR Text Key178340639
Report Number9615742-2020-00059
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
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 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
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: 01/10/2020 Patient Sequence Number: 1
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