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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 PCO15FX
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post operatively, on a laparoscopic umbilical hernia, upon implantation, the mesh was folded at the expanders junction on fascial side against fascial side, and the violet expanders were broken. The wound was closed after the procedure by suturing and there were twenty six fixation points applied. The surgical time was extended by thirty minutes or more due to the product problem and re operation was needed. The incision was extended more than 1 inch. The event lead to or extended the patient's hospitalization for five days.
 
Manufacturer Narrative
Evaluation summary a review of the device history record (dhr) has been performed by quality assurance. No failure or ncr that may relate to the reported conditions have been noted. Especially the records related to the collagen casting and the collagen based film results were found within specifications. The visual examination of the provided sample shows that the sample was not returned in its original packaging but placed in a box. The mesh was found contaminated by blood and a piece of flesh was found in the middle of the mesh. Mesh dimension and textile knitting were found as expected. 25 tacks are visible and well placed and fixed all over the mesh. 2 blue yarns were found on 2 edges of the mesh. The overhang of the collagen film was not present. The mesh was found wet and the collagen film seems to be completely resorbed. The reported condition was confirmed by the piece of flesh present in the middle of the mesh. The reported inflammation, pain and adhesion were known potential complications of this type of surgery. The product instructions for use (ifu) which accompanies each device states in chapter ¿possible complications¿ that ¿the possible complications associated with the use of device optimized composite mesh are those typically associated with surgically implantable materials: seroma/ hematoma / recurrence /adhesions/ chronic pains/ infection / fistula formation/ irritation/ inflammation/ allergic reactions to the components of the product. ¿ 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 indicates that 3 cases coded as "mesh difficult to adhere" 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 reported condition was confirmed but did not occur at the production facilities. The reported conditions are known complication of the procedure. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post operatively, following a laparoscopic intraperitoneal onlay mesh (ipom) procedure for an umbilical hernia, upon implantation, the mesh was folded at the expanders junction on fascial side against fascial side, and the violet expanders were broken. The mesh was explanted due to inflammation and adhesion and the patient was having post operative complications such as pain and coming ileus. The wound was closed after the procedure by suturing and there were twenty six fixation points applied. The surgical time was extended by thirty minutes or more due to the product problem and re operation was needed. The incision was extended more than 1 inch. The event lead to or extended the patient's hospitalization for five days. The surgical time was extended by thirty minutes or more due to the product problem and re-operation was needed. The device was explanted 3 days following implantation.
 
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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 Key7577849
MDR Text Key110349393
Report Number9615742-2018-01240
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179783
UDI-Public10884521179783
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO15FX
Device Catalogue NumberPCO15FX
Device Lot NumberPSC0176X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
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: 06/07/2018 Patient Sequence Number: 1
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