NXSTAGE SYSTEM ONE SAK-304

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for NXSTAGE SYSTEM ONE SAK-304 manufactured by Nxstage Medical, Inc..

Event Text Entries

[100510216] The product was not retained for investigation. Additional information was requested but was not received. Biocompatibility of the device has been established. Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10


[100510217] A report was received on (b)(6) 2018 regarding a (b)(6) -year-old male patient who was hospitalized for 14 days. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003464075-2018-00007
MDR Report Key7284417
Date Received2018-02-20
Date of Report2018-02-20
Date of Event2018-01-30
Date Mfgr Received2018-01-30
Device Manufacturer Date2017-08-07
Date Added to Maude2018-02-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. PAULA ROGALSKI
Manufacturer StreetNXSTAGE MEDICAL, INC 350 MERRIMACK STREET
Manufacturer CityLAWRENCE MA 01843
Manufacturer CountryUS
Manufacturer Postal01843
Manufacturer Phone9786874700
Manufacturer G1MEDIMEXICO S. DE R. L. DE C. V
Manufacturer StreetAV. VALLE IMPERIAL NO. 10523 PARQUE INDUSTRIAL VALLE SUR
Manufacturer CityTIJUANA 22180
Manufacturer CountryMX
Manufacturer Postal Code22180
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNXSTAGE SYSTEM ONE
Generic NameHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Product CodeFKR
Date Received2018-02-20
Model NumberSAK-304
Catalog NumberSAK-304
Lot Number70879045
ID Number+M535SAK3040/$$061970879045E
Device Expiration Date2019-06-18
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNXSTAGE MEDICAL, INC.
Manufacturer Address350 MERRIMACK STREET LAWRENCE MA 01843 US 01843


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-02-20

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