ANSELL ENCORE LATEX ACCLAIM SIZE 6 CE00086

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for ANSELL ENCORE LATEX ACCLAIM SIZE 6 CE00086 manufactured by Ansell Healthcare Products Llc.

Event Text Entries

[137541246] While donning the gloves, holes in the fingers were identified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084471
MDR Report Key8377851
Date Received2019-02-27
Date of Report2019-02-12
Date of Event2019-02-01
Date Added to Maude2019-02-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 Report0

Device Details

Brand NameANSELL ENCORE LATEX ACCLAIM
Generic NameSURGEON'S GLOVES
Product CodeKGO
Date Received2019-02-27
Model NumberSIZE 6
Catalog NumberCE00086
Lot Number1712571504
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCTS LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-27

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