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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR HEMAGARD CAROTID PATCH ULTRATHIN; VASCULAR GRAFT PROSTHESIS
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INTERVASCULAR HEMAGARD CAROTID PATCH ULTRATHIN; VASCULAR GRAFT PROSTHESIS Back to Search Results
Model Number HGK10/75CPUT (1)
Device Problem Material Discolored (1170)
Patient Problem Not Applicable (3189)
Event Date 05/25/2014
Event Type  malfunction  
Event Description
The hosp reported that the patch could not be used because it was found with yellow spots.A new patch was used for the surgery.No device has been returned at the time of this report.
 
Manufacturer Narrative
No device eval was performed since the device has not been returned.A review of the device history records indicated that the product was processed and inspected according to procedures.Specifically, the record of the final visual inspection indicated no anomaly.No conclusion can be drawn.
 
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Brand Name
HEMAGARD CAROTID PATCH ULTRATHIN
Type of Device
VASCULAR GRAFT PROSTHESIS
Manufacturer (Section D)
INTERVASCULAR
zi athelia 1
la ciotat cedex 1360 5
FR  13605
Manufacturer Contact
pascal de framond
zi athelia 1
la ciotat cedex 13605
FR   13605
42084646
MDR Report Key4002083
MDR Text Key4957598
Report Number1640201-2014-00022
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K983819
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 06/02/2014
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 Health Professional
Device Expiration Date11/30/2018
Device Model NumberHGK10/75CPUT (1)
Device Catalogue NumberHGK10/75CPUT (1)
Device Lot Number13M05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2014
Initial Date FDA Received06/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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