WALLSTENT ENDOPROSTHESIS 26280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-13 for WALLSTENT ENDOPROSTHESIS 26280 manufactured by Boston Scientific Corporation.

Event Text Entries

[183514821] Date of event: no date provided, used the first date in the month of the aware date. Implant date: no date provided, used the first date in the month of the aware date.
Patient Sequence No: 1, Text Type: N, H10


[183514822] It was reported that the patient experienced an allergic reaction. A 18x60 10fr 75cm wallstent endoprosthesis was placed in the patient. The patient experienced an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03138
MDR Report Key9829612
Report SourceCONSUMER
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-02-01
Date Mfgr Received2020-02-24
Device Manufacturer Date2017-10-27
Date Added to Maude2020-03-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLSTENT ENDOPROSTHESIS
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeJCT
Date Received2020-03-13
Model Number26280
Catalog Number26280
Lot Number0021308383
Device Expiration Date2019-10-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-13

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