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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 PCO2015X
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); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Discharge (2225); Hernia (2240); Injury (2348); Deformity/ Disfigurement (2360); Sedation (2368); Ascites (2596); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
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 abdominal pain, abdominal distention, and a wound with persistent draining sinus, chronic infected mesh, abscess, mesh failure, pain, mental anguish, permanent and severe scarring and disfigurement, mesh erosion, mesh contraction, adhesions, fistula, inflammation, foreign body response, scar tissue, loss of intestinal domain, multiple small bowel loops within the subcutaneous space consistent with loss of domain, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage. Post-operative patient treatment included 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, resection of the infected mesh, draining of the rectus muscle abdominal wall abscess, repair of an incisional hernia, the patient had to undergo a subcutaneous tissue washout and wound vac change under intravenous sedation, 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.
 
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 abdominal pain, abdominal distention, and a wound with persistent draining sinus, chronic infected mesh and necrotic material, abscess, mesh failure, pain, mental anguish, permanent and severe scarring and disfigurement, mesh erosion, mesh contraction, adhesions, fistula, inflammation, foreign body response, scar tissue, loss of intestinal domain, multiple small bowel loops within the subcutaneous space consistent with loss of domain, organ perforation, recurrence, dyspareunia, blood loss, erythema, neuropathic and other acute and chronic nerve damage. Post-operative patient treatment included 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, resection of the infected mesh, draining of the rectus muscle abdominal wall abscess, repair of an incisional hernia, the patient had to undergo a subcutaneous tissue washout and wound vac change under intravenous sedation, 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.
 
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 was implanted with a mesh device to repair a recurrent incisional hernia. Subsequent to the implantation of the device, the patient began to have abdominal pain, abdominal distention, and a wound with persistent draining sinus among other symptoms. Approximately 2 months and 2 weeks post op the patient underwent surgery to treat chronic infected mesh, resect the infected mesh, drain the rectus muscle abdominal wall abscess and repair an incisional hernia. Subsequent to the resection surgery the patient continued to have problems with infection. The patient had to undergo a subcutaneous tissue washout and wound vac change under intravenous sedation. The patient continues to suffer from abdominal pain and abdominal distention. The mesh failed, causing 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 with 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, adhesions, fistula, inflammation, foreign body response, 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 Key6851466
MDR Text Key253901393
Report Number9615742-2017-05220
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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
Report Date 10/09/2019
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 Date09/30/2013
Device Model NumberPCO2015X
Device Catalogue NumberPCO2015X
Device Lot NumberPLJ00107
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
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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