Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. NONE
  • 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
 

ATRIUM MEDICAL CORP. NONE Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
A sales representative was given an email that announced the problems another facility was having with mesh being "rejected" in five patients out of 46 patients.Representative talked to person that wrote letter and they have narrowed it down to one surgeon and it was determined to be due to technique.
 
Manufacturer Narrative
We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further information is provided, a follow up report will be submitted.The other four reports are: 1219977-2014-00044, -00045, -00046, -00047.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NONE
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
theresa morin, mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3688053
MDR Text Key4256406
Report Number1219977-2014-00048
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2013
Initial Date FDA Received02/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
-
-