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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT
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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
Title: reoperation for recurrence is affected by type of mesh in laparoscopic ventral hernia repair: a nationwide cohort study source: annals of surgery. Doi: 10. 1097/sla. 0000000000005206, year: 2021. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source, the aim of this retrospective study was to compare the reoperation rate for recurrence between different mesh types in laparoscopic ventral hernia repair between 2007 and 2020. There were 2,802 patients with primary hernias and 2,608 with incisional hernias included in the study. There were 895 patients in the primary group and 784 patients in the incisional group received mesh. Post-operative complications included: deep wound infection and hernia recurrence requiring reoperation.
 
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Brand NameUNKNOWN PARIETEX PRODUCT
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key12753621
MDR Text Key280207112
Report Number9615742-2021-02403
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
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: 11/04/2021 Patient Sequence Number: 1
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