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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 Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
Patient Problems Pocket Erosion (2013); Patient Problem/Medical Problem (2688)
Event Date 04/09/2020
Event Type  Injury  
Manufacturer Narrative
Pending follow-up from reporter, including specific device information. (b)(4).
 
Event Description
Received voluntary medwatch 5094218 from fda. Health professional reported a prometra ii pump that may be explanted due to alleged erosion. Report states, "patient was implanted with prometra ii flowonix pump 2017. The pump was placed in the left rear flank and was in approved location. The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port. Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device. This produces contact on the overlying dermal layers and could cause this failure. Now, due to covid-19, we are reluctant to go to hospital to replace or remove. Managing with oral antibiotics and reducing dose. ".
 
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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
Manufacturer Contact
james bennett
500 international drive
suite 200
mount olive, nj 
4269229
MDR Report Key10017772
MDR Text Key189627281
Report Number3010079947-2020-00232
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,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2017
Device Model Number13827
Device Catalogue Number13827
Device Lot Number22676
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2017
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: 05/01/2020 Patient Sequence Number: 1
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