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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 Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's pump was explanted.The reason for the explant is currently unknown.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Additional information was received concerning plant explant.
 
Event Description
A health care professional reported that the patient elected to have the pump explanted.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Corrected informaion was received concerning pump explant.
 
Event Description
It was reported that the patient's pump had flipped and surgical intervention was taken to explant the pump.A catheter access port dye study was performed on the explanted pump and a leak was also observed at the pump stem.
 
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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
MDR Report Key8140436
MDR Text Key129567328
Report Number3010079947-2018-00227
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102370817180520
Combination Product (y/n)N
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2018
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? No
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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