FDA.reportPublic FDA data

MAUDE MDR 6597656

MDR report key
6597656
Report number
MW5070059
Event key
0
Event type
3
Date of event
2017-05-11
Date received
2017-05-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POWDERED GLOVESPOWDERED GO=OFES.UNKLYYI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-250

Event Narratives#

D

Patient 1

THE FDA RECENTLY BANNED POWDERED GLOVES DUE TO THE POWDER BEING A DANGER TO THE USER OF THE PRODUCT. THE SAME POWDER WHICH HAS BEEN BANNED IS ALLOWED IN FOOD SERVICE BECAUSE THEY ARE NOT CLASSIFIED AS MEDICAL DEVICE. USE IS STILL A HAZARD REGARDLESS OF INTENDED USE. INCIDENT LOCATION: SCHOOL. MAY WE INCLUDE YOUR REPORT, INCLUDING ANY DOCUMENTS OR PHOTOGRAPHS THAT YOU HAVE ATTACHED TO YOUR REPORT, BUT WITHOUT YOUR NAME AND CONTACT INFORMATION, IN CPSC'S PUBLIC DATABASE: YES. I CERTIFY THAT I HAVE REVIEWED THE REPORT AND THAT THE INFORMATION PROVIDED IN THIS REPORT IS TRUE AND ACCURATE TO THE BEST OF MY KNOWLEDGE, INFORMATION AND BELIEF: YES. DOCUMENT NUMBER: (B)(4).