ESTEEM XP NITRILE * N8853XP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-05 for ESTEEM XP NITRILE * N8853XP manufactured by Cardinal Health Inc..

Event Text Entries

[18868701] When rn put on gloves, there was a small hole in the glove (on top of thumb). Glove was not punctured and was pulled directly from box without difficulty. No harm to patient or staff. Hole was visibly evident. Another glove obtained and care continued. This facility has had multiple similar events with this device/product within a two month time span. The manufacturer has been notified and is testing the device/product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3672176
MDR Report Key3672176
Date Received2014-03-05
Date of Report2014-02-24
Date of Event2013-12-10
Report Date2014-02-24
Date Reported to FDA2014-03-05
Date Reported to Mfgr2014-03-11
Date Added to Maude2014-03-11
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameESTEEM XP NITRILE
Generic NamePATIENT EXAMINATION GLOVE
Product CodeLZC
Date Received2014-03-05
Model Number*
Catalog NumberN8853XP
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityN
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH INC.
Manufacturer Address1430 WAUKEGAN RD-MPKB-2B MCGAW PARK IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-05

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