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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 PCO3728FX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735); Chest Pain (1776); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pleural Effusion (2010); Tachycardia (2095); Hernia (2240); Distress (2329); Injury (2348); Depression (2361); Impaired Healing (2378); Diaphoresis (2452); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 a diaphragmatic hernia. It was reported that after implant, the patient experienced physical pain, mental anguish, depression, and hernia recurrence. Post-operative treatment included anterior ventral hernia repair and removal of the mesh. After removal, the patient required additional implants of mesh and recurrent hernia repairs.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key9320063
MDR Text Key166303434
Report Number9615742-2019-03725
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110663
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
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberPCO3728FX
Device Catalogue NumberPCO3728FX
Device Lot NumberPPA0498X
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/29/2015
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: 11/14/2019 Patient Sequence Number: 1
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