• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM MESH FOR VENTRAL HERNIA

  • 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 MESH FOR VENTRAL HERNIA Back to Search Results
Lot Number PNF0279
Device Problem Microbial Contamination of Device (2303)
Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Abdominal Distention (2601)
Event Date 10/20/2014
Event Type  Injury  
Event Description
The reporter stated that "i have had 3 surgeries due to this mesh that was implanted on (b)(6) 2014 and i never got better. I had an abscess in (b)(6) and had to have surgery. On (b)(6) 2015 the mesh became infected and i had to have another surgery. They removed part of the mesh in (b)(6). My stomach is bloated and distented. I have a lot of pain and my gastro reflux has gotten worse.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH FOR VENTRAL HERNIA
Type of DeviceMESH
Manufacturer (Section D)
SOFRADIM
MDR Report Key7086600
MDR Text Key94073182
Report NumberMW5073747
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot NumberPNF0279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/05/2017 Patient Sequence Number: 1
-
-