• 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 Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Atrial Flutter (1730); Fistula (1862); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Myocardial Infarction (1969); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Seroma (2069); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 chronic pain, infection, small bowel obstruction, fistula, seroma, small bowel perforation, adhesions, recurrence, abdominal free air and intra-abdominal fluid, inflammation, myocardial infarction, atrial flutter, abdominal distention, large hematomas, nausea, vomiting, hypotension, ischemic and necrotic bowel. Post-operative patient treatment included small bowel resection, lysis of adhesions, removal of mesh from wound, placement of ethicon vicryl mesh, pacemaker implanted, fluid resuscitation, recurrent ventral incisional hernia repair with bard ventralight st mesh, small-bowel resection with a 2 layer hand-sewn anastomosis, and evacuation of large subcutaneous hematoma and seroma.
 
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 incisional hernia. It was reported that after implant, the patient experienced chronic pain, infection, small bowel obstruction, fistula, seroma, small bowel perforation, adhesions and recurrence. Post-operative patient treatment included small bowel resection, lysis of adhesions, removal of mesh from wound, placement of ethicon vicryl mesh, recurrent ventral incisional hernia repair with bard ventralight st mesh.
 
Manufacturer Narrative
(b)(4).
 
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 an incisional herniorrhaphy with mesh. He had revision surgery 1 year and 8 months post surgery then again 2 years later and 3 months later and again 3 months post surgery. The patient experienced multiple surgical revisions, chronic pain, infection, and recurrence.
 
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6944840
MDR Text Key250951417
Report Number9615742-2017-05528
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2015
Device Model NumberPCO2520OS
Device Catalogue NumberPCO2520OS
Device Lot NumberPKF00218
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
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: 10/12/2017 Patient Sequence Number: 1
-
-