VICKS V1200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-17 for VICKS V1200 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.

Event Text Entries

[142232035] Kaz usa, inc. Has requested that the product be returned to our company for testing, but it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10


[142232036] A consumer reported that he received second degree burns on his stomach and right arm from hot water that spilled out of the personal steam inhaler. Medical intervention was sought for their injuries at a walk-in clinic. The consumer stated that he was grabbing the unit away from his wife when the injury occurred. The instructions for proper use have a clear warning that states "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", and "never move the appliance while in use. It can spill hot water if tilted or tipped over causing injury. " kaz usa, inc. Has requested that the product be returned to our company for testing, but the product had already been returned to the retailer. We asked that the consumer contact the retail store to try to recover the unit so that we can test it.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1314800-2019-00023
MDR Report Key8523253
Report SourceCONSUMER
Date Received2019-04-17
Date of Report2019-04-26
Date of Event2019-03-19
Date Mfgr Received2019-03-22
Device Manufacturer Date2018-11-05
Date Added to Maude2019-04-17
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 ContactSONJA WILKINSON
Manufacturer Street400 DONALD LYNCH BOULEVARD SUITE 300
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5084907236
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVICKS
Generic NameELECTRIC STEAM INHALER
Product CodeKFZ
Date Received2019-04-17
Returned To Mfg2019-04-24
Model NumberV1200
Lot Number30918MHD
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKAZ USA, INC., A HELEN OF TROY COMPANY
Manufacturer AddressMARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-04-17

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