BLOX SBT-114-100 60264

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-16 for BLOX SBT-114-100 60264 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2020-00074
MDR Report Key9596415
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-16
Date of Report2020-03-17
Date of Event2019-12-21
Date Mfgr Received2020-02-20
Date Added to Maude2020-01-16
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1JIANGSU JIANYU HEALTH MEDICAL CO LTD
Manufacturer StreetZHIXI INDUSTRY ZONE JINTAN AREA,
Manufacturer CityCHANGZHOU CITY 213251
Manufacturer CountryCH
Manufacturer Postal Code213251
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLOX
Generic NameENDOSCOPIC BITE BLOCK
Product CodeMNK
Date Received2020-01-16
Returned To Mfg2020-01-24
Model NumberSBT-114-100
Catalog Number60264
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

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