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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 Codes Seroma (2069); No Code Available (3191)
Date of Event 02/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Internal complaint number: (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
(b)(4).Additional information was received on december 19, 2018 concerning reason for explant.
 
Event or Problem Description
It was reported that the patient developed a seroma and the pump was subsequently explanted.
 
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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 Key8140422
Report Number3010079947-2018-00222
Device Sequence Number16197006
Product Code LKK
UDI-Device Identifier00810335020082
UDI-Public0100810335020082101996517161215
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P080012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
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 Date12/15/2016
Device Model Number11827
Device Catalogue Number11827
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/06/2018
Supplement Date Received by Manufacturer12/19/2018
Initial Report FDA Received Date12/06/2018
Supplement Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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