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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 UNKNOWN PARIETEX PRODUCT
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Pain (1994); Distress (2329); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 ventral hernia.It was reported that after the implant, the patient experienced pain/suffering, device defective, emotional distress, disability, impairment, loss of enjoyment of life, mental pain, distress, inability to eat and trouble swallowing, and malnutrition.Post-operative patient treatment included revision surgery, and mesh removal.
 
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Brand Name
PARIETEX
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key12746181
MDR Text Key279890174
Report Number9615742-2021-02399
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/13/2021
Initial Date FDA Received11/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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