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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 Seroma (2069); Post Operative Wound Infection (2446)
Event Date 06/02/2019
Event Type  Injury  
Manufacturer Narrative

Title mesh fixation in open ipom procedure with tackers or sutures? a randomized clinical trial with preliminary results source hernia, 2019 date of online publication: 24 june 2019. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operatively, a total of 48 patients were included in the study. The patient's that used mesh and suture fixation had medical complications such as seroma and deep surgical site infection.

 
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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 Key9519515
MDR Text Key173191074
Report Number9615742-2019-03912
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received12/12/2019
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: 12/26/2019 Patient Sequence Number: 1
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