FITGUARD SELECT NITRILE EXAM GLOVES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for FITGUARD SELECT NITRILE EXAM GLOVES manufactured by Medline Industries, Inc..

Event Text Entries

[61152328]
Patient Sequence No: 1, Text Type: N, H10


[61152329] During assist with cleaning a patient, staff noticed three tears on the gloves on the index finger, middle finger and ringer finger.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6135728
MDR Report Key6135728
Date Received2016-11-30
Date of Report2016-10-27
Date of Event2016-10-25
Report Date2016-10-27
Date Reported to FDA2016-10-27
Date Reported to Mfgr2016-10-27
Date Added to Maude2016-11-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 Report3

Device Details

Brand NameFITGUARD SELECT NITRILE EXAM GLOVES
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2016-11-30
ID NumberFG2601
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PL. MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-30

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