FITGUARD SELECT NITRILE EXAM GLOVES 2016-06

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 2016-06 manufactured by Medline Industries, Inc..

Event Text Entries

[61151616]
Patient Sequence No: 1, Text Type: N, H10


[61151617] Glove integrity problem - tore during patient care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6135866
MDR Report Key6135866
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 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 Report3

Device Details

Brand NameFITGUARD SELECT NITRILE EXAM GLOVES
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2016-11-30
Catalog Number2016-06
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 2016-11-30

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