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 Number: MW5084683
• MDR Report Key: 8395966
• Date Received: 2019-03-06
• Date of Report: 2019-01-05
• Date of Event: 2019-01-03
• Date Added to Maude: 2019-03-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VERSEO RECHARGEABLE HOT WATER BOTTLE
• Generic Name: ELECTRIC HOT WATER BOTTLE
• Product Code: FPF
• Date Received: 2019-03-06
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VERSEO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-03-06