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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 Muscle Spasm(s) (1966)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Information concerning the catheter revision was received on 7/16/2018.
 
Event Description
It was reported that the patient was experiencing muscle spasms in her back.A catheter access port (cap) dye study determined there was an issue with the catheter.During the catheter revision, the catheter was found to be kinked.
 
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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 Key7719135
MDR Text Key114997464
Report Number3010079947-2018-00149
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020099
UDI-Public0100810335020099171907281023360
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 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2019
Device Model Number11823
Device Catalogue Number11823
Device Lot Number23360
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2018
Initial Date FDA Received07/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2017
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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