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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPM4530
Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2018
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 hernia procedure, the device was folded unnecessarily many times. There were multiple crease/folds in the device after it is removed from the packaging. These creases make it difficult to implant the device during the procedure.
 
Event Description
According to the reporter, during hernia procedure, the device was folded unnecessarily many times. There were multiple crease/folds in the device after it is removed from the packaging. These creases make it difficult to implant the device during the procedure. The event happen during the procedure but no patient involvement.
 
Manufacturer Narrative
Evaluation summary: one photo of the device was returned for investigation. A review of the device history record has been performed by trevoux quality assurance and no failure that may relate to the reported conditions have been noted. The visual examination of the provided picture shows: a tyvek lid with the reorder code. The lot number and expiration date are not readable. On the right a folded mesh is visible above a container containing liquid. The reported condition was confirmed. It should be noted that the mesh was placed with a robotic-assistance. According to the description of the incident ¿the device was folded unnecessarily many times¿. This is the usual process used for large sizes of meshes, as describe in the manufacturing process / instruction. This folding has been identified in the ris files to prevent damage of the mesh or packaging for large size of meshes. Based on the available information, 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 fault. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePARIETENE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key8106980
MDR Text Key128443131
Report Number9615742-2018-02627
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K142091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPPM4530
Device Catalogue NumberPPM4530
Device Lot NumberSSB1186X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

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