MAUDE MDR 8395966

MDR report key
8395966
Report number
MW5084683
Event key
0
Event type
3
Date of event
2019-01-03
Date received
2019-03-06
Adverse event
0
Product problem
0
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERSEO RECHARGEABLE HOT WATER BOTTLEELECTRIC HOT WATER BOTTLEVERSEOFPFI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-0601. O

Event Narratives#

D

Patient 1

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.