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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 TECT1510AR
Device Problems Material Erosion (1214); Material Perforation (2205); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Emotional Changes (1831); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Hernia (2240); Injury (2348); Deformity/ Disfigurement (2360); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 laparoscopic therapeutic treatment of a reducible right inguinal hernia. It was reported that after implant, the patient experienced abdominal pain, abdominal distention, recurrence, mesh failure, pain, mental anguish, permanent and severe scarring and disfigurement, mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute chronic nerve damage. Post-operative patient treatment included revision surgery, operations to attempt to repair organs, tissue and nerve damage, the use of pain control and other medications, removal of prior mesh and open repair of recurrent right inguinal hernia with c. R. Bard/davol mesh.
 
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 was implanted with a mesh device to repair a right inguinal hernia. Subsequent to the implantation the patient began to have abdominal pain, abdominal distention among other symptoms. The patient experienced a hernia recurrence within six months. Approximately 1 year and 9 months post op the patient underwent an additional surgery at the hospital to repair a recurrent incisional hernia. The patient continues to suffer from abdominal pain and abdominal distention. The mesh failed, caused serious injury and portions of the mesh had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat. The patient has suffered and will continue to suffer both physical injury and pain and mental anguish, and permanent and severe scarring and disfigurement. The patient sustained injuries including but not limited to mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute chronic nerve damage and pain requiring the patient to undergo intensive medical treatment including nut not limited to operations to locate and remove mesh, operations to attempt to repair organs, tissue and nerve damage, and the use of pain control and other medications.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6823188
MDR Text Key109411669
Report Number9615742-2017-05209
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,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model NumberTECT1510AR
Device Catalogue NumberTECT1510AR
Device Lot NumberSNA00260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/22/2013
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: 08/27/2017 Patient Sequence Number: 1
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