CARDINAL FLEXAL NITRILE EXAM GLOVES 88TN02S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for CARDINAL FLEXAL NITRILE EXAM GLOVES 88TN02S manufactured by Cardinal Health 200, Llc.

Event Text Entries

[138908518] Exam gloves and dispensing box have metal flakes found on them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084893
MDR Report Key8420661
Date Received2019-03-13
Date of Report2019-03-04
Date of Event2019-02-24
Date Added to Maude2019-03-14
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 NameCARDINAL FLEXAL NITRILE EXAM GLOVES
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2019-03-13
Returned To Mfg2019-02-25
Catalog Number88TN02S
Lot Number3T18P035
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-13

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