MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE PRO ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M042

Device Problems Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); No Code Available (3191)

Event Date 09/11/2019

Event Type  Injury  

Event Description

My husband purchased a malem bedwetting alarm (ultimate mode) for our (b)(6) y/o daughter.It was intended to help her stop bedwetting.The system beeps when it detects urine.But our alarm has operated dangerously.I explained it to my daughter and set it up for her.She went to bed and within half an hour, she was screaming in her bed.We ran up to her room, only to find her crying and tugging on her shirt.The alarm was super hot.I reached out to remove it, but it was just too hot to hold.I removed her shirt and left the alarm on it.There was burning plastic smell in the room.My daughter was scared and i noticed a big red patch on her neck.That patch was clearly from the hot alarm which burnt her.I took her to the dr's office who said that this is not the first reported incident of a malem alarm injuring a child's sleep.We are so scared to use any other such product.The alarm finally stopped heating up.The batteries leaked out and its shape changed from heat.Daughter recovered from her skin burn but still suffered mental trauma which is still there even after a week.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE PRO ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9082256
• MDR Text Key: 159152188
• Report Number: MW5089856
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 26