• 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 UNKNOWN PARIETEX

  • 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 UNKNOWN PARIETEX Back to Search Results
Model Number UNKNOWN PARIETEX
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Internal Organ Perforation (1987); Hernia (2240); Injury (2348); Prolapse (2475)
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.
 
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 parastomal hernia. It was reported that after implant, the patient experienced bowel perforation, adhesions, prolapsed vagina and recurrence of incarcerated hernia. Post-operative patient treatment included incarcerated incisional hernia repair with mesh placement, laparoscopic lysis of adhesions, laparoscopic transabdominal preperitoneal right inguinal hernia repair with mesh and partial small bowel resection.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 laparoscopic lysis of adhesions (1 hour) and laparoscopic repair of parastomal hernia with mesh due to recurrent parastomal hernia. The patient underwent an additional implant approximately 1 year and 6 months post op and another approximately 2 years and 11 months post op. The patient had a revision surgery approximately 5 years post op. The patient experienced bowel perforation, adhesions, and recurrence of incarcerated hernia.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN PARIETEX
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6875529
MDR Text Key258186865
Report Number9615742-2017-05272
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 09/19/2017 Patient Sequence Number: 1
-
-