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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1509G
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Injury (2348); Deformity/ Disfigurement (2360); Blood Loss (2597); 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent implantation of mesh for a left inguinal hernia. Subsequent to the implantation of the mesh, the patient began to suffer debilitating pain, infection, sexual dysfunction, and other symptoms. The doctor had advised against attempts to surgically remove the mesh in order to alleviate symptoms as it would be too dangerous. The patient has suffered physical injury, pain, mental anguish, permanent and severe scarring and disfigurement. The patient sustained injuries, including by not limited to, mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, requiring the patient to undergo intensive medical treatment, including but not limited to operations to locate and remove mesh, operations to attempt to repair organs, tissue, and nerve damage, the use of pain control and other medication, as well as other severe and permanent health consequences.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ PROGRIP¿
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6991368
MDR Text Key90704729
Report Number9615742-2017-05588
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM1509G
Device Catalogue NumberTEM1509G
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
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: 10/31/2017 Patient Sequence Number: 1
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