• 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 SYMBOTEX 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 SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Lot Number PRK1515X
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2019
Event Type  malfunction  
Event Description
Tissue came through the mesh. Mesh was removed and replaced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYMBOTEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
covidien
60 middletown ave
north haven CT 06473
MDR Report Key8472706
MDR Text Key140592979
Report Number8472706
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberPRK1515X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2019
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer04/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-