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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP

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FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 13827
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)
Event Date 09/20/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was that a patient with an implanted prometra ii 20 ml pump went to the hospital with increased pain and withdrawal symptoms and received treatment for break thru pain after having used more than the expected amount of medication. The patient had the pump explanted and replacement with a larger 40ml pumps due to the alleged over infusion. It was also reported that the patient did feel sleepier than normal previous week.
 
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Brand NamePROMETRA II PROGRAMMABLE PUMP
Type of DeviceIMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer (Section G)
FLOWONIX MEDICAL, INC.
120 forbes blvd
suite 170
mansfield MA 02048
Manufacturer Contact
james bennett
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key9593305
MDR Text Key185188702
Report Number3010079947-2020-00189
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
Type of Report Initial,Followup
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2018
Device Model Number13827
Device Catalogue Number13827
Device Lot Number24320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/15/2020 Patient Sequence Number: 1
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