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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN MESH PRODUCT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN MESH PRODUCT
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); 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 recurrence, adhesions, infections, mesh mitigration, pain, mental anguish, scarring and disfigurement, defective device, loss of enjoyment of life, suffering, and mesh failure. Post-operative patient treatment included additional surgery, and mesh removal.
 
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Brand NameUNKNOWN MESH PRODUCT
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 80301
3035816943
MDR Report Key14349007
MDR Text Key291323662
Report Number9615742-2022-00439
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN MESH PRODUCT
Device Catalogue NumberUNKNOWN MESH PRODUCT
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/10/2022 Patient Sequence Number: 1
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