ULTIMATE PRO BEDWETTING ALARM
Received Sep 15, 2020 · Event occurred Sep 10, 2020
Report MW5096669 · MDR key 10540929
Device
Generic name
Alarm, Conditioned Response Enuresis
Manufacturer
Malem Medical Ltd.Product problems
- Melted
- Overheating of Device
- Smoking
Patient
8 YR
- Scarring
- Burn, Thermal
- Scarring
- Burn, Thermal
Narrative
Description of Event or Problem
A BRAND NEW MALEM ALARM PURCHASED FROM (B)(6) HAS MALFUNCTIONED THE FIRST TIME IT WAS USED. I INSERTED BATTERIES THAT CAME WITH THE ALARM AND AS I WAS PLACING IT ON MY SON, IT STARTED TO SMELL AND I NOTICED FUMES COMING FROM THE TOP OF THE ALARM. THE BACK SIDE GOT SO HOT THAT IT PARTIALLY MELTED AND FUSED TO MY SONS SHIRT. HE WAS LAYING IN BED AND THE ALARM SCARRED HIM PARTIALLY ON HIS NECK. I WAS SO SCARED THAT THE ALARM WOULD CATCH FIRE OR BURST. I QUICKLY MADE MY SON REMOVE HIS SHIRT AND THREW IT ON THE FLOOR. AFTER 30 MINUTES, THE SHIRT WAS BURNT AND THERE WAS A BIG HOLE IN THE SHIRT WHERE THE ALARM WAS CONNECTED. ALSO THE ALARM PLASTIC MELTED AND THE DEVICE IS NOT USABLE. TOO DANGEROUS AND WE ARE SCARED TO TRY ANOTHER DEVICE LIKE THIS IN THE FUTURE. FDA SAFETY REPORT ID# (B)(4).