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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000306-00
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Received report of a hair in the package.
 
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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8521144
MDR Text Key142210839
Report Number3011175548-2019-00406
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000306-00
Device Catalogue Number1000306-00
Device Lot Number438164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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