BEDWETTING ALARM DEVICE
Received Aug 6, 2020 · Event occurred Aug 2, 2020
Report MW5095948 · MDR key 10379042
Device
Generic name
Alarm, Conditioned Response Enuresis
Manufacturer
Malem Medical, Ltd.Model number
ULTIMATE ALARMProduct problems
- Melted
- Overheating of Device
- Smoking
Patient
7 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE REPORT IS CONCERNING A MALEM BEDWETTING ALARM. THIS ALARM WAS PURCHASED IN NEW CONDITION FROM THE MANUFACTURER. ONCE I INSERTED BATTERIES, IT STARTED VIBRATING WITHOUT SENSOR AND THERE WAS NO WAY TO TURN IT OFF. I REMOVED THE BATTERIES AND REINSERTED THEM IN. BUT THAT DID NOT HELP. AFTER 5 MINUTES OF VIBRATION, SMOKE STARTED COMING OUT OF THE ALARM, AND IT WAS SUPER HOT. THE PLASTIC HOUSING WAS BENDING FROM HEAT. THIS IS SO SCARY AND DANGEROUS. I HAD TO USE OVEN MITTS TO OPEN THE ALARM AND REMOVE THE BATTERIES. IF MY SON WAS SLEEPING WITH THIS ALARM, IT WOULD HAVE BEEN VERY DANGEROUS AND EASILY BURNT HIM. FDA SAFETY REPORT ID# (B)(4).