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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable. Occupation: non-healthcare professional the event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

It is alleged that the patient received a gunther tulip on (b)(6) 2008. It is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8745307
MDR Text Key149542276
Report Number1820334-2019-01555
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
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 TREATMENT DATA
Date Received: 06/28/2019 Patient Sequence Number: 1
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