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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 Kinked (1339)
Patient Problem Pain (1994)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The patient experienced increased pain.A catheter access port (cap) dye study was performed and the physician believed there was a kink in the catheter.It was reported on (b)(6) 2018, that the catheter was subsequently revised.
 
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Brand Name
PROMETRA INTRATHECAL CATHETER KIT
Type of Device
IMPLANTABLE 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 Key7363755
MDR Text Key103264911
Report Number3010079947-2018-00053
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020099
UDI-Public0100810335020099171510221020375
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 Physician
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/22/2015
Device Model Number11823
Device Catalogue Number11823
Device Lot Number20375
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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