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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA INTRATHECAL CATHETER KIT IMPLANTABLE INTRATHECAL CATHETER KIT

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FLOWONIX MEDICAL, INC. PROMETRA INTRATHECAL CATHETER KIT IMPLANTABLE INTRATHECAL CATHETER KIT Back to Search Results
Model Number 11823
Device Problem Defective Device (2588)
Patient Problem Pain (1994)
Event Date 08/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient went to the emergency room for increased pain. A catheter access port (cap) dye study was performed by the patient's pain management physician and the catheter was observed to be occluded. The catheter was subsequently replaced.
 
Manufacturer Narrative
Internal complaint number: (b)(4). Additional information was received on 9/5/2018 concerning the catheter.
 
Event Description
A health care professional reported that the patient was taken to the operating room and the catheter was checked and confirmed to be patent. The catheter was therefore not replaced.
 
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Brand NamePROMETRA INTRATHECAL CATHETER KIT
Type of DeviceIMPLANTABLE INTRATHECAL CATHETER KIT
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
karen matis
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key7832595
MDR Text Key118754327
Report Number3010079947-2018-00175
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/10/2018
Device Model Number11823
Device Catalogue Number11823
Device Lot Number22565
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 Received08/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2016
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: 08/30/2018 Patient Sequence Number: 1
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