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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 PCO2015FX
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); Cyst(s) (1800); Emotional Changes (1831); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Hernia (2240); Injury (2348); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced a procedure to repair a mechanical small bowel obstruction where it was indicated there was an inflammatory mass that consisted of some elements of the mesh, abdominal pain, abdominal distention, mesh failure physical pain, mental anguish, permanent and severe scarring and disfigurement, mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage. Post-operative patient treatment included exploratory laparotomy, enterolysis, excision of urachal cyst, reapproximation of abdominal wall, revision surgeries to locate and remove mesh, as well as, operations to attempt to repair organs, tissue, and nerve damage, and the use of pain control and other medications. Subsequent to the implantation of the mesh device the patient began to have abdominal pain and other symptoms. Within a matter of days, the patient was diagnosed with a small bowel obstruction.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 an incisional hernia repair. Subsequent to the implantation of the mesh device the patient began to have abdominal pain and other symptoms. Within a matter of days, the patient was diagnosed with a small bowel obstruction. Approximately 9 days post op the patient underwent an additional procedure to repair a mechanical small bowel obstruction where it was indicated there was an inflammatory mass that consisted of some elements of the mesh which had turned so that the side without the seprafilm form of protection was exposed to a few small bowel limbs. 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 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 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, and the use of pain control and other medications.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6851521
MDR Text Key109913821
Report Number9615742-2017-05222
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2015
Device Model NumberPCO2015FX
Device Catalogue NumberPCO2015FX
Device Lot NumberPND0061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
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: 09/08/2017 Patient Sequence Number: 1
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