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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 TEC1515
Device Problems Failure To Adhere Or Bond (1031); Product Quality Problem (1506); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter: a mesh was inserted during a tapp procedure and was fixed with glubran (apside). Postoperatively it was discovered that 1 out of 10 times when the surgeon would stick the plate with the glubran it did not stick well. The surgeon thought there was a coating of the plate that was not always identical.

 
Manufacturer Narrative

Additional information was received and this file was determined to not be reportable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter: a mesh was inserted during a tapp procedure and was fixed with glubran (apside). The mesh seemed to be hydrophobic. When the surgeon use glu with the mesh, it seems to be difficult 10% of the time. For him, he thinks meshes are not all the time the same. He thinks that mesh is covered by something which is not uniform.

 
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Brand NamePARIETEX
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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6503053
MDR Text Key73254611
Report Number9615742-2017-05092
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTEC1515
Device Catalogue NumberTEC1515
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
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

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