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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM; MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 5230-150
Device Problem Torn Material (3024)
Patient Problem Hernia (2240)
Event Date 01/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient underwent an initial operation on (b)(6) 2016 for a recurrent hernia, and the device was implanted.On (b)(6) 2016, the patient got a "burst" stomach due to relapsing cough.An immediate re-operation was necessary.During the reoperation, the device was found to be ripped in the area of the fixation seams.It was also found to have defects in the net area where no seam fixation was made.The device was explanted.
 
Manufacturer Narrative
(b)(4).A visual examination of the returned device revealed the following: the sample was not returned in its original packaging but in a container with saline solution; the mesh had been cut; there were holes and a tear at different locations of the mesh (not only at the fixation points); and the tears were not in the direction of the fibers.It was determined, based on the physical evaluation of the device, that a combination of potential residual infection of the implantation site and excessive tension on the mesh due to chronic coughing may have induced the observed tears and holes.Based on the instructions for use (ifu) that accompany the device, it is stated that if the surgical implant is shaped too small for the defect, excessive tension may be placed on the sutures and possibly result in recurrence of the original tissue defect or development of a defect in the adjacent tissues.As the device was cut prior to implantation, it is not known if there was adequate overlap to ensure sufficient margins for incorporation to the surrounding tissues.A review of the device history record (dhr) has been performed.This review confirmed that this lot of products was reviewed and released according to quality specifications, including records related to bioburden and sterilization.Should additional information become available, the record will be re-evaluated and amended as needed.
 
Event Description
Additional information indicated that the mesh was saved in a sodium chloride solution.The reconstruction was performed with a non-absorbable mesh, despite the raised risk of infection (per the doctor's words).It was also reported that the mesh did not provide enough stability.
 
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Brand Name
PERMACOL 20X30 1.5MM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR 
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR  
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5467368
MDR Text Key39264215
Report Number9615742-2016-00006
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2016
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
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Model Number5230-150
Device Catalogue Number5230-150
Device Lot NumberAOL0559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2016
Initial Date FDA Received02/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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