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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
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). The event is currently under investigation.
 
Event Description
It is alleged that "[pt] received a gunther tulip/gunther (1820334-2016-01442) tulip mreye (1820334-2016-01441) on (b)(6) 06 at (b)(6) hospital in (b)(6). " it is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
It is alleged that "[pt] received a gunther tulip (1820334-2016-01442)/ gunther tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6). " it is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Additional information provided confirmed the plaintiff received one filter (1820334-2016-01442) instead of two filters as originally alleged (1820334-2016-01441). Cook is cancelling the file related to 1820334-2016-01441.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6151884
MDR Text Key61649543
Report Number1820334-2016-01441
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue 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 Received01/31/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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