CHEMOPLUS - CHEMOTHERAPY PATIENT EXAMINATION GLOVES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for CHEMOPLUS - CHEMOTHERAPY PATIENT EXAMINATION GLOVES manufactured by Covidien.

Event Text Entries

[145835255] Chemo plus gloves produce powder like substance after spraying down with alcohol.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086787
MDR Report Key8627839
Date Received2019-05-20
Date of Report2019-05-16
Date of Event2019-05-16
Date Added to Maude2019-05-21
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 Report0

Device Details

Brand NameCHEMOPLUS - CHEMOTHERAPY PATIENT EXAMINATION GLOVES
Generic NameLATEX PATIENT EXAMINATION GLOVES
Product CodeLYY
Date Received2019-05-20
Lot Number807829902
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-20

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