CURAPLEX PVC NASOPHYRANGEAL AIRWAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for CURAPLEX PVC NASOPHYRANGEAL AIRWAY manufactured by Unk.

Event Text Entries

[181528273] Npa appropriately measured and sized for pt. Npa migrated into lower airway due to poorly designed flange which is not rigid enough and collapses. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093303
MDR Report Key9754193
Date Received2020-02-25
Date of Report2020-02-21
Date of Event2019-08-15
Date Added to Maude2020-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter 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 NameCURAPLEX PVC NASOPHYRANGEAL AIRWAY
Generic NameAIRWAY, NASOPHARYNGEAL
Product CodeBTQ
Date Received2020-02-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-25

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