CAPIO DEVICE CARRIER M0068311250

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-25 for CAPIO DEVICE CARRIER M0068311250 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report NumberMW5091290
MDR Report Key9376623
Date Received2019-11-25
Date of Report2019-11-20
Date of Event2019-07-03
Date Added to Maude2019-11-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAPIO DEVICE CARRIER
Generic NameHOLDER, NEEDLE GASROENTEROLOGIC
Product CodeFHQ
Date Received2019-11-25
Model NumberM0068311250
Lot Number19980158
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-25

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