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

Model Number ULTIMATE PRO FOR BOYS AND GIRLS

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

Patient Problem Burn, Thermal (2530)

Event Date 07/26/2019

Event Type  Injury  

Event Description

Last night was the first time we used the bedwetting alarm and it was a very scary incident for us.At 1:30 am, my son was screaming and shouting in his room.When we reached, i saw that he had moved the alarm and it was on the floor.I asked him what happened and he said that the alarm burnt him.I picked up the alarm and it was very hot like it was on fire.I kicked it off the carpet (which was stained) and on to the floor.My boy said that his neck was burning.I gave him first aid treatment and will take him to the dr's office today.I checked on the alarm later and it was not responding.It was stinking of plastic burning and batteries leaked out.Back underside has changed shape.Plastic possibly melted.Dangerous and scary experience for us.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8847674
• MDR Text Key: 153225360
• Report Number: MW5088575
• 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: 07/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO FOR BOYS AND GIRLS
• Device Catalogue Number: M042
• Device Lot Number: BLUE
• 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