HIGH FIVE NITRILLE GLOVES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-03 for HIGH FIVE NITRILLE GLOVES manufactured by Bosma Enterprises.

Event Text Entries

[18733199] On staff interview, they had trouble with the gloves sticking together, and are not usable due to gloves being torn in half, and many with large holes. Staff complain that they tear when applying them, and may have a hole in the fingers that aren't identified prior to using the gloves on patients. The small and medium are especially defective. A black substance was found on some of the gloves, but the package was not saved to get a lot number. One of the gloves was saved. Some of the staff complaints related to the quality: end of finger tips missing or completely gone before putting on two or three fingers missing in gloves when going to put them on, three fingers and part of main glove missing, obviously gone before putting them on and black stuff on gloves. One box was awful with black substance are on gloves. Ripped at cuff before even putting them on into glove before even putting them together. Gloves that have parts of another glove melted into them in the palm area, very rough, bumpy and obvious. Gloves wrinkled and not able to palpate veins or soft tissue well. The gloves in the bags feel like they are melted together. Have to pull them apart with difficulty by using two hands and not just able to pull them individually. You can try to get one glove and end up picking up the whole bag/box of gloves as they are that stuck together. Cannot shake them loose. Diagnosis or reasons for use: hand protection from blood-borne pathogens and cleaning item.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038530
MDR Report Key4155924
Date Received2014-10-03
Date of Report2014-10-03
Date of Event2014-09-25
Date Added to Maude2014-10-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHIGH FIVE NITRILLE GLOVES
Generic NameHIGH FIVE NITRILLE GLOVES
Product CodeLYY
Date Received2014-10-03
Lot Number14844-2610402
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerBOSMA ENTERPRISES
Manufacturer AddressINDIANAPOLIS 46268 46268


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-03

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