NITRILE EXAM GLOVES REF 88TN025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for NITRILE EXAM GLOVES REF 88TN025 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[132582741] Employee removed gloves directly from box and donned gloves when she noticed a sharp piece of plastic embedded in glove poked her hand.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082921
MDR Report Key8227886
Date Received2019-01-07
Date of Report2018-12-31
Date of Event2018-12-21
Date Added to Maude2019-01-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNITRILE EXAM GLOVES
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2019-01-07
Model NumberREF 88TN025
Lot Number4R17J025
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address7000 CARDINAL PLACE DUBLIN OH 43017 US 43017


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-07

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