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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, PRODUCT CODE: LKK
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FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP, PRODUCT CODE: LKK Back to Search Results
Model Number 13827
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 09/29/2017
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was reported that the pump rotated medially to the incision site causing the patient to experience pain. The pump was revised on (b)(6) 2017.
 
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Brand NamePROMETRA II PROGRAMMABLE PUMP
Type of DeviceIMPLANTABLE INFUSION PUMP, PRODUCT CODE: LKK
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
sofia fernandez
500 international drive
suite 500
mount olive, NJ 07828
MDR Report Key7036457
MDR Text Key92162027
Report Number3010079947-2017-00162
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 study
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/22/2017
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2016
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: 11/16/2017 Patient Sequence Number: 1
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