• 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¿ 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¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO15
Device Problems Patient-Device Incompatibility (2682); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Syncope (1610); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Erythema (1840); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Pneumonia (2011); Renal Failure (2041); Sepsis (2067); Tachycardia (2095); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); Bowel Perforation (2668); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Syncope/Fainting (4411); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
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. The product was used for therapeutic treatment of a hernia.
 
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. The product was used for therapeutic laparoscopic treatment of an incisional hernia. After treatment, the patient experienced infection, fistula, recurrence, adhesions, loculated fluid pockets in the abdomen, abdominal free air, peritonitis with abscesses, ileal stricture, klebsiella pneumonia and e. Coli. , elevated creatinine, chronic active ileitis consistent with crohn's disease, perforation and abscess formation, serositis with marked fibrosis, acute and chronic inflammation, edematous colonic mucosa, necrosis, progressing abdominal problems with gross stool and passing out, bowel perforation, pocket of purulent material in all quadrants of abdomen, dense phlegmonous tissue, dilated and inflamed bowel, ileum edematous, thick rind around bowel, acute septicemia, severe anemia and acute respiratory failure, persistent fistula, open wounds noted above umbilicus with drainage, edema, necrotic and infected debris and erythema, colo (sigmoid) cutaneous fistula, bacterial sepsis with tachycardia, acute renal failure, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and hypotension. Post-operative patient treatment included cholecystectomy, lysis of adhesions, small bowel resection, transfer to intensive care, antibiotics, multiple fluid boluses, blood transfusions, postoperative ventilator, and revision surgery.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SOFRADIM - PARIETEX¿ 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 Key7757501
MDR Text Key116253006
Report Number9615742-2018-01824
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2015
Device Model NumberPCO15
Device Catalogue NumberPCO15
Device Lot NumberPKB00246
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: 08/07/2018 Patient Sequence Number: 1
-
-