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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 TEC3030
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Anemia (1706); Bacterial Infection (1735); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Renal Failure (2041); Scar Tissue (2060); Seroma (2069); Thrombus (2101); Vomiting (2144); Weakness (2145); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Blood Loss (2597); Fibrosis (3167); No Code Available (3191); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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. Product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced infection, abscess, chronic open wound, sinus tracts, mesh unincorporated, necrotic tissue, fistula, recurrence, bacterial infection, inflammation, seroma, fibrohistiocytic reaction, foreign body reaction, fibrosis, scar tissue, hemorrhage, cellulitis, purulent material, pain, fevers, tenderness, edema, lower gastrointestinal bleed, chronic iron deficiency anemia, renal failure, nausea, vomiting, diarrhea, blood loss, hypotension, free floating mesh, weakness, intravascular volume depletion, chills, blood clot, boil on abdomen, empyema, and mesh migration. Post-operative patient treatment included revision surgeries, antibiotics, explantation of mesh, repair of hernia with mesh, debridement of necrotic tissue, incision and drainage of abscess, medications, hospitalized, excisional debridement of scar and subcutaneous tissue, debridement of skin tissue, and wound vac.
 
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. Product was used for therapeutic treatment of an abdominal hernia. It was reported that after implant, the patient experienced infection, abscess, chronic open wound, sinus tracts, mesh unincorporated, necrotic tissue, fistula, recurrence, and mesh migration. Post-operative patient treatment included revision surgeries, partial excision, explantation of mesh, repair of hernia with mesh, debridement of necrotic tissue, and wound vac.
 
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. Product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, infection, abscess, chronic open wound, sinus tracts, mesh unincorporated, necrotic tissue, fistula, recurrence, bacterial infection, staphylococcus aureus, inflammation, seroma, fibrohistiocytic reaction, foreign body reaction, fibrosis, scar tissue, hemorrhage, cellulitis, purulent material, pain, fevers, tenderness, edema, lower gastrointestinal bleed, chronic iron deficiency anemia, renal failure, nausea, vomiting, diarrhea, blood loss, hypotension, free floating mesh, weakness, intravascular volume depletion, chills, blood clot, boil on abdomen, empyema, and mesh migration. Post-operative patient treatment included revision surgeries, antibiotics, explantation of mesh, repair of hernia with mesh, debridement of necrotic tissue, incision and drainage of abscess, medications, hospitalized, excisional debridement of scar and subcutaneous tissue, debridement of skin tissue, and wound vac.
 
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 a hernia repair with mesh. The patient experienced abscess, chronic infection, chronic open wound, sinus tracts, unincorporation, and 10 surgeries to remove all mesh with an additional 5-6 surgeries to debride necrotic tissue (approx 19-20 surgeries total to remove mesh and treat injuries).
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key6955392
MDR Text Key247054268
Report Number9615742-2017-05558
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2014
Device Model NumberTEC3030
Device Catalogue NumberTEC3030
Device Lot NumberSJF00591
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
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: 10/17/2017 Patient Sequence Number: 1
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