• 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 PCOPM20
Device Problem Torn Material (3024)
Patient Problems Tissue Damage (2104); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)
Event Date 07/28/2017
Event Type  Injury  
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
According to the reporter: occurred post-operatively, approximately 1 year and 8 months after receiving a composite parastomal mesh as part of a modified sugarbaker repair for a rectal extirpation for cancer.The original repair included composite parastomal mesh fixed with permanent tackers and sutures.The patient did not present with any immediate problems following the procedure.He returned to the hospital due to an acutely developed small bowel obstruction.He underwent emergency laparoscopic surgery where a small bowel loop was discovered inside a fracture hole in the mesh.The bowel loop was vital and was repositioned following repair of the mesh hole with nylon suture.The mesh appeared normal besides the fracture hole.The issue caused temporary injury and tissue damage and required surgical intervention.Patient status reported as alive, no injury.Relevant medical history: rectal extirpation for cancer.
 
Manufacturer Narrative
Evaluation summary: an evaluation was performed on the device.The visual examination of the provided picture shows a well-integrated mesh in vivo with a similar knitting pattern than pcopm meshes.At least 14 tacks are surrounded a big hole in the textile (>10 pores).However due to the picture quality, it is not possible to determine where exactly is located the hole in the mesh (2d-band or 3d-band), if it is a tear or a cut, and if the mesh have been overstretched or not.Without the sample a detailed investigation could not be performed.Conclusion of the visual examination: the root cause could not be determined.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PARIETEX
Type of Device
MESH, 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 avenue
north haven, CT 06473
2034925267
MDR Report Key6831993
MDR Text Key84020943
Report Number9615742-2017-05211
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177789
UDI-Public10884521177789
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K081126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Model NumberPCOPM20
Device Catalogue NumberPCOPM20
Device Lot NumberPPE0509X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2017
Initial Date FDA Received08/30/2017
Supplement Dates Manufacturer Received09/05/2017
Supplement Dates FDA Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight104
-
-