MAUDE Adverse Event Report: VERSEO VERSEO RECHARGEABLE HOT WATER BOTTLE; ELECTRIC HOT WATER BOTTLE

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 01/03/2019

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: VERSEO RECHARGEABLE HOT WATER BOTTLE
• Type of Device: ELECTRIC HOT WATER BOTTLE
• Manufacturer (Section D): VERSEO
• MDR Report Key: 8395966
• MDR Text Key: 138028774
• Report Number: MW5084683
• Device Sequence Number: 1
• Product Code: FPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR