FITGUARD SELECT NITRILE EXAM GLOVE FG2601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for FITGUARD SELECT NITRILE EXAM GLOVE FG2601 manufactured by Medline Industries Inc..

Event Text Entries

[63077761]
Patient Sequence No: 1, Text Type: N, H10


[63077762] During donning of the gloves, easily ripped at top of the sleeve. Recurring problem at hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6197978
MDR Report Key6197978
Date Received2016-12-22
Date of Report2016-12-07
Date of Event2016-11-11
Report Date2016-12-07
Date Reported to FDA2016-12-07
Date Reported to Mfgr2016-12-07
Date Added to Maude2016-12-22
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 GLOVE
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2016-12-22
Model NumberFG2601
Catalog NumberFG2601
Lot NumberEG608642733
Device AvailabilityY
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 2016-12-22

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