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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP.
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ATRIUM MEDICAL CORP. Back to Search Results
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Type  Injury  
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 info is provided a follow up report will be submitted.The other four reports are: 1219977-2014-00045, 00046, 00047 and 00048.
 
Event Description
A sales rep was given an email that announced the problems another facility was having with mesh being "rejected" in five patients out of 46 patients.Rep talked to person that wrote letter and they had narrowed it down to one surgeon and it was determined to be due to technique.
 
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Manufacturer (Section D)
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson NH 03051
Manufacturer Contact
theresa morin, complaints mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3687784
MDR Text Key21273912
Report Number1219977-2014-00044
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;
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