• 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 PARIETEX 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 PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO1510OSX
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559)
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. It was reported that after implant, the patient experienced small bowel adhered to mesh, hernia recurrence, small bowel perforation, fluid discharge, abscess, small bowel eroded into the anterior wall mesh, and large mass of small bowel scarring. Treatment provided for these conditions include lysis of adhesions, surgical revision with new mesh, irrigation and drainage, small bowel resection, and transgastric jejunostomy tube was placed.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced small bowel adhered to mesh, lateral aspect of mesh pulled away, hernia recurrence, small bowel perforation, fluid discharge, abscess, small bowel eroded into the anterior wall mesh, infection, obstruction, pain, seroma, and large mass of small bowel scarring. Treatment provided for these conditions include lysis of adhesions, surgical revision with new mesh, irrigation and drainage, small bowel resection, transgastric jejunostomy tube was placed, extended hospital stay, icu, and suture repair of small bowel perforation.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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, CT 80301
3035816943
MDR Report Key8131974
MDR Text Key129295138
Report Number9615742-2018-02679
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110816
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 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model NumberPCO1510OSX
Device Catalogue NumberPCO1510OSX
Device Lot NumberPNH0264X
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/25/2013
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: 12/05/2018 Patient Sequence Number: 1
-
-