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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 PCO20X
Device Problems Material Erosion (1214); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Adult Respiratory Distress Syndrome (1696); Bacterial Infection (1735); Erosion (1750); Dyspnea (1816); Emotional Changes (1831); Encephalopathy (1833); Fever (1858); Fistula (1862); Hypoxia (1918); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Muscle Weakness (1967); Necrosis (1971); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Pneumothorax (2012); Sepsis (2067); Septic Shock (2068); Tachycardia (2095); Thrombosis (2100); Vomiting (2144); Weakness (2145); Chills (2191); Hernia (2240); Hypernatremia (2242); Distress (2329); Discomfort (2330); Injury (2348); Depression (2361); Coma (2417); Fungal Infection (2419); Obstruction/Occlusion (2422); Sweating (2444); Diaphoresis (2452); Respiratory Failure (2484); Lethargy (2560); Ascites (2596); Abdominal Distention (2601); No Code Available (3191); Constipation (3274); Thrombosis/Thrombus (4440); Respiratory Insufficiency (4462); Unspecified Tissue Injury (4559)
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 hernia. It was reported that after implant, the patient experienced an adverse outcome.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key8756558
MDR Text Key149908855
Report Number9615742-2019-02350
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179677
UDI-Public10884521179677
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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,Followup
Report Date 10/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberPCO20X
Device Catalogue NumberPCO20X
Device Lot NumberPOA0381X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/23/2014
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: 07/03/2019 Patient Sequence Number: 1
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