• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO9X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Dehydration (1807); Diarrhea (1811); Purulent Discharge (1812); Gangrene (1873); Gastritis (1874); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Septic Shock (2068); Vomiting (2144); Chills (2191); Cramp(s) (2193); Discharge (2225); Hernia (2240); Hypovolemia (2243); Anxiety (2328); Injury (2348); Impaired Healing (2378); Diaphoresis (2452); Sleep Dysfunction (2517); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); 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 a ventral incisional hernia. It was reported that after implant, the patient experienced abscess, open wound, recurrence, adhesions, mesh migration, infection leading to septic shock, adhesions to bowel, septic shock lead to ischemia of toes, leading to gangrene and foot amputation, fluid collection, pyelonephritis/cystitis, worsening leukocytosis, bacterial infection, inflammation, fibroadipose tissue, hemorrhage, fibrosis, serositis, rigor, abdominal pain, hypotension, diaphoretic, dehydration, hypoperfusion, acute kidney injury, hypovolemia, lactic acidosis, mild rhabdomyolysis, purulent fluid, hematoma, discharge, wound dehiscence, necrosis, gastritis, bleeding, pericarditis, cellulitis, nausea, pain, scarring, vomiting, chills, cramping, insomnia, anxiety, pulmonary embolism, black tarry diarrhea, and osteomyelitis. Post-operative patient treatment included revision surgery, bowel resection, surgeries to clear infection, hernia repair, explantation of mesh, fascial closure, foot amputation, implantation of mesh, antibiotics, admitted to the icu for fluid resuscitation, placement of negative pressure wound vacuum dressing, non-viable tissue removed, scar excision, lysis of adhesions, 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 a ventral incisional hernia. It was reported that after implant, the patient experienced abscess, open wound, recurrence, adhesions, mesh migration, infection leading to septic shock, adhesions to bowel, septic shock lead to ischemia of toes, leading to gangrene and foot amputation. Post-operative patient treatment included revision surgery, bowel resection, surgeries to clear infection, hernia repair, explantation of mesh, fascial closure, foot amputation, implantation of mesh, and wound vac.
 
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 a hernia repair with mesh. The patient experienced infection leading to septic shock, adhesions to bowel, bowel resection, multiple surgeries to clear infection and repair hernia, septic shock lead to ischemia of toes, leading to gangrene and foot amputation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key6964683
MDR Text Key247064520
Report Number9615742-2017-05566
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberPCO9X
Device Catalogue NumberPCO9X
Device Lot NumberPOE0130X
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2014
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: 10/20/2017 Patient Sequence Number: 1
-
-