TRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG 25067

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-07 for TRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG 25067 manufactured by Young Innovations Llc Dba Plak Smacker.

Event Text Entries

[61654102] Customer has mentioned that the device will be returned for an evaluation but didn't receive it yet.
Patient Sequence No: 1, Text Type: N, H10


[61654103] Plak smacker received a complaint saying doctor's hands turned red and itchy when she used plak smaker hand gloves. Doctor didn't receive any medical treatment and her symptoms cleared up.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024980-2016-00006
MDR Report Key6152447
Report SourceCOMPANY REPRESENTATIVE
Date Received2016-12-07
Date of Report2016-11-08
Date of Event2016-10-17
Date Mfgr Received2016-10-17
Date Added to Maude2016-12-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMRS ASMITA PATEL
Manufacturer Street2260 WENDT ST
Manufacturer CityALGONQUIN IL 60102
Manufacturer CountryUS
Manufacturer Postal60102
Manufacturer Phone8474585642
Manufacturer G1YOUNG INNOVATIONS LLC DBA PLAK SMACKER
Manufacturer Street2260 WENDT ST.
Manufacturer CityALGONQUIN IL 60102
Manufacturer CountryUS
Manufacturer Postal Code60102
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG
Generic NameTRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG
Product CodeLZA
Date Received2016-12-07
Catalog Number25067
OperatorDENTAL HYGIENIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerYOUNG INNOVATIONS LLC DBA PLAK SMACKER
Manufacturer Address2260 WENDT ST. ALGONQUIN IL 60102 US 60102


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.