STAYFREE MAXI WINGS LONG SUPER UNSCENTED PADS 7830007022

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-06 for STAYFREE MAXI WINGS LONG SUPER UNSCENTED PADS 7830007022 manufactured by Edgewell Personal Care Canada, Ulc.

MAUDE Entry Details

Report Number2515444-2016-00013
MDR Report Key6149323
Date Received2016-12-06
Date of Report2016-11-08
Date of Event2016-10-18
Date Facility Aware2016-10-18
Report Date2016-10-18
Date Reported to Mfgr2016-10-18
Date Mfgr Received2016-10-18
Date Added to Maude2016-12-06
Event Key0
Report Source CodeDistributor report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS GALE LYDIC
Manufacturer Street185 SAULSBURY RD
Manufacturer CityDOVER DE 19904
Manufacturer CountryUS
Manufacturer Postal19904
Manufacturer Phone3026786429
Manufacturer G1PLAYTEX MANUFACTURING, INC.
Manufacturer Street805 WALKER RD
Manufacturer CityDOVER DE 19904
Manufacturer CountryUS
Manufacturer Postal Code19904
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTAYFREE MAXI WINGS LONG SUPER UNSCENTED PADS
Generic NamePAD, MENSTRUAL, UNSCENTED
Product CodeHHD
Date Received2016-12-06
Catalog Number7830007022
Lot Number15212M4227
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age15 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDGEWELL PERSONAL CARE CANADA, ULC
Manufacturer Address7101 NOTRE DAME ST. EAST MONTREAL, QUEBEC H1N 2G4 CA H1N 2G4



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