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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC

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COOK INC Back to Search Results
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 02/13/2019
Event Type  Injury  
Manufacturer Narrative

Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, on (b)(6) 2019 a (b)(6) year old female underwent the removal of a gunther tulip inferior vena cava (ivc) filter placed in 2002. Lot and product number were not provided. During the procedure, the filter was found to be fractured with half of a leg retained locally and relatively loose in the ivc. The filter and the locally retained leg were removed with forceps. Post procedure, the patient complained of pain. No medical intervention was reported. The patient is currently doing well. The initial reporter provided a copy of the hhs fda sus report which was submitted to fda on 13feb2019. The facility reference number was not provided. During follow up with the initial reporter, it was stated there was no health history to provide. Patient medical records will not be provided. Additionally, the complaint device will be retained by the facility. A photo of the removed device was supplied to the manufacturer.

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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key8354608
MDR Text Key136731698
Report Number1820334-2019-00229
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 02/20/2019 Patient Sequence Number: 1