• 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 PCO2520X
Device Problems 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 Adhesion(s) (1695); Erythema (1840); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191); Unspecified Tissue Injury (4559)
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. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, adhesions, healing impaired, erythematous tissue, mesh was coming off the anterior abdominal wall and organ perforation. Post-operative patient treatment included excision of infected mesh, recurrent ventral hernia repair with strattice mesh, robotically assisted laparoscopic hernia repair with bard xenmatrix graft, lysis of adhesions, incisional hernia repair with bard alloderm and component separation.
 
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. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, adhesions and organ perforation. Post-operative patient treatment included excision of infected mesh, recurrent ventral hernia repair with strattice mesh, robotically assisted laparoscopic hernia repair with bard xenmatrix graft, lysis of adhesions, incisional hernia repair with bard alloderm and component separation.
 
Manufacturer Narrative
(b)(4). 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 open repair recurrent incisional hernia and extensive lysis of adhesions. He had revision surgery 10 months post-surgery. The patient underwent recurrent incisional hernia. The patient experienced infection, recurrence and organ perforation.
 
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 Key7122563
MDR Text Key247366786
Report Number9615742-2017-06127
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2520X
Device Catalogue NumberPCO2520X
Device Lot NumberPIJ006255
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2021
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: 12/15/2017 Patient Sequence Number: 1
-
-