ALAIR? M005ATS25010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for ALAIR? M005ATS25010 manufactured by Boston Scientific Corporation.

Event Text Entries

[121731815] Bronchial thermoplasty cathether kept flashing red on monitor and would not deliver a charge. Had to replace with another one and then there were no problems.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7909538
MDR Report Key7909538
Date Received2018-09-26
Date of Report2018-09-19
Date of Event2018-09-18
Report Date2018-09-19
Date Reported to FDA2018-09-19
Date Reported to Mfgr2018-09-26
Date Added to Maude2018-09-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALAIR?
Generic NameBRONCHIAL THERMOPLASTY SYSTEM
Product CodeOOY
Date Received2018-09-26
Model NumberM005ATS25010
Catalog NumberM005ATS25010
Lot Number21694581
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-26

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