InjuryKPN
BEDWETTING ALARM
Received Jun 23, 2020 · Event occurred Jun 15, 2020
Report MW5095181 · MDR key 10189373
Device
Product problems
- Explosion
Patient
8 YR
- Pain
- Swelling
- Injury
- Burn, Thermal
- Pain
- Swelling
- Injury
- Burn, Thermal
Narrative
Description of Event or Problem
BURNS; THE BEDWETTING ALARM HAS MALFUNCTIONED IN THE MIDDLE OF THE NIGHT, JUST 30 MINUTES INTO MY SONS SLEEP. THE ALARM EXPLODED CAUSING BATTERIES TO LEAK AND CAUSE NECK INJURIES. MY SON WAS SLEEPING ON HIS STOMACH WHEN THE EXPLOSION HAPPENED. WE HAD TO TAKE HIM TO THE ER IN THE MIDDLE OF THE NIGHT. IT IS UNFORTUNATE. HE WAS INJURED AND HAS BLISTERS (PAINFUL) ON HIS NECK. WE ARE FRIGHTENED TO USE THE BEDWETTING ALARM AND HIS WETTING HAS GOTTEN WORSE. FDA SAFETY REPORT ID # (B)(4).