CRE? PULMONARY M00550310 5031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for CRE? PULMONARY M00550310 5031 manufactured by .

Event Text Entries

[91187680] For the 1 event reported under exemption number (b)(4), the product has been returned but analysis has not yet been completed.
Patient Sequence No: 1, Text Type: N, H10


[91187681] The manufacturer report is being sent as a requirement under summary reporting exemption approval number - (b)(4) for product code kti. This report summarizes 1 reported event of balloon leak. It was reported that the patient was over 18 years of age. All other demographic information is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2017-03248
MDR Report Key6980445
Date Received2017-10-26
Date of Report2017-10-01
Date Added to Maude2017-10-26
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 ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRE? PULMONARY
Generic NameBRONCHOSCOPE ACCESSORY
Product CodeKTI
Date Received2017-10-26
Model NumberM00550310
Catalog Number5031
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-26

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