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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 TECR1410DP2
Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, on a laparoscopic totally extraperitoneal inguinal hernia repair, after the insertion to the patient during mesh deployment and placement, there appeared to be a knot in the thread. When the surgeon went to pull the thread out of the mesh to position it inside the patient, the thread kept gathering and pulling the mesh. There was a knot which the surgeon had to cut to remove the thread and deploy the mesh. The thread then came out in 2 separate pieces. Extra time of about 15 minutes was added to the procedure due to the issue. There was no patient injury.

 
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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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10707865
MDR Text Key212256011
Report Number9615742-2020-02371
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberK982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTECR1410DP2
Device Catalogue NumberTECR1410DP2
Device LOT NumberSUC0867M
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 Received09/29/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/19/2020
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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