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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUMED, INC. COVERED CP STENT; AORTIC STENT
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NUMED, INC. COVERED CP STENT; AORTIC STENT Back to Search Results
Model Number 427
Device Problem Torn Material (3024)
Patient Problem No Information (3190)
Event Date 05/26/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned to numed.It is being held by the fda at customs.A photograph of the covered cp stent was sent to numed along with the complaint.From the pictures it appears that the covering and the glue spots are still intact.Numed can't at this time confirm this complaint.If more information becomes available, a follow-up report will be sent in.Being held at customs by the fda.
 
Event Description
As per the report from the (b)(6) distributor - "professor brown opened the stent and it looked like the outer coating had been ripped.Professor opted to rather open and use another cvrd 45 stent with no problems.".
 
Manufacturer Narrative
The device has not yet been returned to numed.It is being held by the fda at customs.A photograph of the covered cp stent was sent to numed along with the complaint.From the pictures it appears that the covering and the glue spots are still intact.Numed can't at this time confirm this complaint.If more information becomes available, a follow-up report will be sent in.Update - 7/10/2017 - device returned to numed.Visual inspection was performed by the vp of r&d, and there was no problem found with this device.All adhesive spots were confirmed with no issues found, and the covering was still attached to the stent with no issues found.
 
Event Description
As per the report from the (b)(6) distributor - "professor (b)(6) opened the stent and it looked like the outer coating had been ripped.Professor opted to rather open and use another cvrd 45 stent with no problems.".
 
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Brand Name
COVERED CP STENT
Type of Device
AORTIC STENT
Manufacturer (Section D)
NUMED, INC.
2880 main street
hopkinton NY 12965
Manufacturer (Section G)
NUMED, INC.
2880 main street
hopkinton NY 12965
Manufacturer Contact
nichelle laflesh
2880 main street
hopkinton, NY 12965
3153284491
MDR Report Key6669168
MDR Text Key78608464
Report Number1318694-2017-00016
Device Sequence Number1
Product Code PNF
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P150028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/31/2021
Device Model Number427
Device Catalogue NumberCVRDCP8Z45
Device Lot NumberCCP-0711
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/30/2017
Initial Date FDA Received06/27/2017
Supplement Dates Manufacturer Received05/30/2017
Supplement Dates FDA Received07/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age13 YR
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