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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
Device Problems Premature End-of-Life Indicator (1480); Device Issue (2379)
Patient Problem No Code Available (3191)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Results provided upon completion of evaluation.
 
Event Description
It was reported that the pump was explanted due to steady tone emission and inability to inquire pump.
 
Manufacturer Narrative
(b)(4).Device evaluation determined that the pump battery had reached eol prematurely.The cause of the battery depleting prematurely could not be determined.
 
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Brand Name
PROMETRA PROGRAMMABLE PUMP
Type of Device
IMPLANTABLE INFUSION PUMP
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 Key7405036
MDR Text Key104664679
Report Number3010079947-2018-00062
Device Sequence Number1
Product Code LKK
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,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date04/01/2016
Device Model Number11827
Device Catalogue Number11827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? No
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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