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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
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/19/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter occupation: manager. (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 that an unknown cook spectrum picc device broke. The device was implanted on (b)(6) 2021. Medicines administered through the device potentially include fosphenyoin and acyclovir. As a result of the break, the patient had another device placed ("rewired") and was reported to have "did well". Additional information regarding the patient, device, and event has been requested but is not available.
 
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Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11287045
MDR Text Key230546252
Report Number1820334-2021-00264
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received07/01/2021
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

Patient Treatment Data
Date Received: 02/05/2021 Patient Sequence Number: 1
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