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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL PROLITE ULTRA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30802
Device Problems Contamination /Decontamination Problem (2895); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
When the outer packing was opened they found some foreign matter inside the wrap. The matter was faint yellow and at the edge of the mesh.
 
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Brand NamePROLITE ULTRA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7911891
MDR Text Key122041528
Report Number3011175548-2018-01035
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number30802
Device Catalogue Number30802
Device Lot Number424151
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2017
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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