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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 Device Issue (2379)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's pump flipped and was unable to communicate with the clinician programmer.The patient experienced inadequate pain relief and the pump was subsequently explanted.
 
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Brand Name
PROMETRA II 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 Key7582781
MDR Text Key110494243
Report Number3010079947-2018-00115
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102132717160722
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 Physician
Type of Report Initial
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/22/2016
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
Date Manufacturer Received05/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2016
Is the Device Single Use? Yes
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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