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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP
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FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 11827
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/20/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the patient's pump was explanted.The reason for the explant is currently unknown.
 
Additional Manufacturer Narrative
Internal complaint number: (b)(4).Additional information was received concerning pump explant.
 
Event or Problem Description
A health care professional reported that the patient elected to have pump explanted.There was no pump malfunction.
 
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Brand Name
PROMETRA PROGRAMMABLE PUMP
Common Device Name
IMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
MDR Report Key8140444
Report Number3010079947-2018-00234
Device Sequence Number16381257
Product Code LKK
UDI-Device Identifier00810335020082
UDI-Public0100810335020082101982117161030
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P080012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/06/2018
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? No
Operator of Device Health Professional
Device Expiration Date10/30/2016
Device Model Number11827
Device Catalogue Number11827
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/06/2018
Supplement Date Received by Manufacturer11/06/2018
Initial Report FDA Received Date12/06/2018
Supplement Report FDA Received Date01/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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