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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378); 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 hernia. It was reported that after implant, the patient experienced purulent drainage, staph growing, irrigation and debridement of wound. Post-operative patient treatment included revision surgery.
 
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 hernia. It was reported that after implant, the patient experienced purulent drainage, staph growing, irrigation and debridement of wound. Post-operative patient treatment included revision surgery.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key8487510
MDR Text Key141059509
Report Number9615742-2019-01040
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2016
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPLE00409
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/05/2019 Patient Sequence Number: 1
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