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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 Problems Failure To Adhere Or Bond (1031); Product Quality Problem (1506)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 07/07/2017
Event Type  malfunction  
Manufacturer Narrative
Medtronic complaint number: (b)(4). An evaluation of the mesh was performed. The visual examination of the photographs found the samples as expected: one layer of white textile, one layer of green textile, two expanders (one white and one blue) correctly positioned on the mesh, a collagen film; the violet expander on the side of the white handle seems to have been broken at 1 location. The mesh was folded collagen film face against collagen film face. Based on the examination: the mesh was not folded correctly by the user: collagen film side against collagen film side instead of textile side against textile side. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate. If information is provided in the future, a supplemental report will be issued.
 
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: occurred during an open para umbilical hernia 1. 5cm defect repair procedure with intraperitoneal onlay mesh (ipom) technique. When the surgeon attempted to place the mesh, one side was infolding and not placed into the parietal wall. The mesh was folded at the two violet expander junctions. The mesh was folded fascial side against fascial side. The appearance of the mesh was white and dry. In order to resolve the issue and complete the case, the surgeon used a different type of mesh and the wound was closed using suture. The surgical time was extended by thirty minutes or more due to the product problem. There was no patient harm. The patient outcome is alive, no injury.
 
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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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6769936
MDR Text Key166709087
Report Number9615742-2017-05197
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberPCO6VP
Device Catalogue NumberPCO6VP
Device Lot NumberPOL0742X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/23/2014
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: 08/06/2017 Patient Sequence Number: 1
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