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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TCM1510X3
Medical Device Problem Codes Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104); Constipation (3274)
Date of Event 05/03/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, postoperatively, either the mesh or tacks used had torn the surrounding organs or tissues.The net shrank and caused bleeding.The patient had chronic pain in the groin, and a chronic painful constipation.
 
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Brand Name
PARIETEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key9357284
Report Number9615742-2019-03783
Device Sequence Number18952424
Product Code FTL
UDI-Device Identifier10884521178861
UDI-Public10884521178861
Combination Product (Y/N)N
Initial Reporter CountryDA
PMA/510(K) Number
K090858
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/30/2020
Device Model NumberTCM1510X3
Device Catalogue NumberTCM1510X3
Device Lot NumberSPL0336X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2019
Initial Report FDA Received Date11/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age51 YR
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