• 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 PCO2520OS
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Laceration(s) (1946); Pain (1994); Scar Tissue (2060); Scarring (2061); Cramp(s) (2193); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); 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 an incarcerated incisional hernia. It was reported that after implant, the patient experienced recurrence of an incisional hernia that was incarcerated and painful, erosion, adhesions, loops of small bowel adherent to the mesh, and wrinkled mesh causing bowel obstruction. Treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, hernia repair with sutures, and later explant of the mesh.
 
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 80301
3035816943
MDR Report Key8440181
MDR Text Key139450556
Report Number9615742-2019-00542
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
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 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2014
Device Model NumberPCO2520OS
Device Catalogue NumberPCO2520OS
Device Lot NumberPJH00031
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
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: 03/21/2019 Patient Sequence Number: 1
-
-