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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO4VP
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2017
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer reference number: (b)(4). Patient information not provided. Implant and explant date were not provided. Lot number not provided. Udi not provided. Occupation of initial reporter not provided.

 
Event Description

According to the reporter: during an umbilical hernia repair, the surgeon did not feel that he could get the mesh to lay flat against tissue. There was no injury to the patient.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The event report alleges the product was used in a surgical procedure. One unit was received; however, only the white handle was received. Damage was observed on the violet expander side of the handle in two different locations. The film was observed to be broken and torn in multiple locations, most likely a result of incorrect folding of the mesh observed on the sample; the mesh was folded with the collagen side on the interior surface relative to the fold. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Replication of this may occur if the collagen is not folded properly. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. 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.

 
Manufacturer Narrative

Corrected information:no eval explain code. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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Brand NamePARIETEX
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 Key6367268
MDR Text Key68599685
Report Number9615742-2017-05024
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO4VP
Device Catalogue NumberPCO4VP
Device LOT NumberPQG0669X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2016
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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