BOSMA ENTERPRISES 72-10501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-11 for BOSMA ENTERPRISES 72-10501 manufactured by Bosma Enterprises.

Event Text Entries

[4759692] A nurse put on a new glove out of the box and it contained an unknown oily substance with a black substance mixed in. The glove was then removed from use. Will send to manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038201
MDR Report Key4096458
Date Received2014-09-11
Date of Report2014-09-10
Date of Event2014-09-08
Date Added to Maude2014-09-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBOSMA ENTERPRISES
Generic NameSIZE SMALL NITRILE EXAM GLOVES, HIGH FIVE PERFORMANCE GLOVES
Product CodeLYY
Date Received2014-09-11
Returned To Mfg2014-09-12
Model Number72-10501
Lot Number15063-261406
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerBOSMA ENTERPRISES
Manufacturer AddressINDIANAPOLIS IN 46268 US 46268


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-11

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