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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO6VP
Device Problem Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an umbilical hernia repair procedure, while inserting the mesh, it was brittle and the strap broke. A new device was used to complete the case. No injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: one device was returned for investigation. A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted. Especially the records related to the molding of the ring and the handles positioning were found within specifications. The visual examination of the returned sample shows that: the sample was returned in its original packaging (aluminum pouch, tray petg and tyvek lid). The commercial box was not provided. The sample was found contaminated by blood. The mesh dimension, sewing and the removable handles were found as expected. The collagen film was partially detached from the mesh, mainly around the mesh. The expanders were broken at 2 points: 1. A break at the quarter of the junction, on the side of the white handle 2. A break at half of the junction on the side of the blue handle the reported condition was confirmed. User error the mesh was broken in 2 sides of the pgla expanders, not in the normal location for folding the mesh. The product instructions for use (ifu) which accompanies each device states in chapter ¿operating steps ¿ positioning¿ that ¿3. Fold the hydrated parietex¿ composite ventral patch in half along the junction of the two violet expanders. ¿ a search of our global complaints database revealed that this was the only report on file for this lot of product. The review of historical data (complaint records from 25 january 2013 (initial ce-mark) to 30 november 2018) indicates that 5 cases (b)(4) coded as -mesh degradation- were reported. The report has been added to our product complaints database which is monitored for similar occurrences. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. No immediate action required. The root cause is user error. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
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 Key8119709
MDR Text Key128893145
Report Number9615742-2018-02632
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO6VP
Device Catalogue NumberPCO6VP
Device Lot NumberPSF0891X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2018
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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