VERSEO RECHARGEABLE HOT WATER BOTTLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for VERSEO RECHARGEABLE HOT WATER BOTTLE manufactured by Verseo.

Event Text Entries

[138028774] I purchased two verseo rechargeable hot water bottles in (b)(6) 2017 through (b)(6) online, one i gave as a gift, the other i kept for myself. I have used it many times. This past week i have used it almost every night since i have a sinus infection. I plugged it in. The unit is supposed to charge and then you can unplug it and it retains heat for a few hours. Within a few minutes i heard a shotgun like sound and water exploded everywhere and it was sizzling. My back was toward it so i have burns on my back from hot water hitting my back. I have pictures of my back and kept the exploded bottle as well. I immediately contacted my family to notify them to stop using their bottle as a precaution. Luckily it was only myself and my pets in the room at the time and this did not occur while unplugged and in "actual us on a physical body part", i cannot imagine the pain and extreme burn that would have caused. This item needs to be investigated so this does not happen to another individual. I have emailed the company and have not yet received a response. Product description: verseo rechargeable hot water bottle-color blue i can still pull up the original order form with picture of item from (b)(6). Retailer: (b)(6), retailer state: online, purchase date: (b)(6) 2017, explanation: i have emailed the company.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084683
MDR Report Key8395966
Date Received2019-03-06
Date of Report2019-01-05
Date of Event2019-01-03
Date Added to Maude2019-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSEO RECHARGEABLE HOT WATER BOTTLE
Generic NameELECTRIC HOT WATER BOTTLE
Product CodeFPF
Date Received2019-03-06
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerVERSEO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-06

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