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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 Problems Material Erosion (1214); Material Puncture/Hole (1504); Appropriate Term/Code Not Available (3191)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 10/26/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was reported that the patient had a cerebrospinal fluid (csf) leak and the catheter was subsequently revised.During the revision, a segment of the catheter was found to be eroded and had developed a hole.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Device evaluation determined that there was a hole in the catheter caused by two sections of catheter rubbing against each other for a prolonged period of time.
 
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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
MDR Report Key8105510
MDR Text Key128394307
Report Number3010079947-2018-00218
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020099
UDI-Public0100810335020099171508021019897
Combination Product (y/n)N
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/02/2015
Device Model Number11823
Device Catalogue Number11823
Device Lot Number19897
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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