inforMED
InjuryKPN

BEDWETTING ENURESIS ALARM

Received May 12, 2020 · Event occurred May 8, 2020

Report MW5094466 · MDR key 10051379

Device

Generic name

Alarm, Conditioned Response Enuresis

Manufacturer

Malem Medical Ltd.

Model number

M04SB

Catalog number

M04SB

Product problems

  • Product Quality Problem

Patient

7 YR

  • Discomfort
  • Electric Shock
  • Discomfort
  • Electric Shock

Narrative

Description of Event or Problem

THIS MALEM BEDWETTING ALARM IS TERRIBLE. IT DOES NOT WORK AS DESCRIBED. IT DOESN'T DETECT URINE EVEN WHEN IT'S SUPPOSED TO AND RINGS WITH SCARY TONES WHEN IT'S DRY. IT'S HARD TO PROGRAM, WE FOLLOWED THE DIRECTIONS AND IT DOESN'T WORK. THE SENSOR IS EXTREMELY UNCOMFORTABLE, IT KEPT HURTING MY CHILD IN HIS GROIN ALL THE TIME. WHEN MY SON HAD BEDWETTING ACCIDENT, THE SENSOR GAVE HIM A BIG BAD SHOCK IN HIS GROIN AT NIGHT. HE WAS SCARED, WORRIED AND CRIED. THE ALARM KEPT GIVING HIM A SHOCK TILL I HEARD HIM CRY AND WENT TO HIS ROOM TO REMOVE IT. OVERALL THIS IS A SUBSTANDARD OVERPRICED TOY. WE ARE VERY DISAPPOINTED WITH THIS PRODUCT. I VERY MUCH REGRET THE MONEY WE WASTED ON THIS AND DO NOT RECOMMEND IT AT ALL. THIS PRODUCT HAS DEMOTIVATED MY SON AND NOW HIS BEDWETTING HAS GONE WORSE. FDA SAFETY REPORT ID # (B)(4).