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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 PCO4VP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Staphylococcus Aureus (2058); Scar Tissue (2060); Discharge (2225); Hernia (2240); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of incisional ventral and umbilical hernias. It was reported that after implant, the patient experienced explant of infected mesh x2, evacuation of hematoma, wound vac, draining pus, new mesh; hernia recurrence requiring placement of new mesh, peritoneum cleared. Post-operative patient treatment included revision surgery.
 
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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 Key8491799
MDR Text Key141207546
Report Number9615742-2019-01087
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2016
Device Model NumberPCO4VP
Device Catalogue NumberPCO4VP
Device Lot NumberPNG0252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/25/2013
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: 04/08/2019 Patient Sequence Number: 1
Treatment
PCO8VP LOT NUMBER: PNE0674
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