MAUDE Adverse Event Report: MALAM MEDICAL LTD. BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE ALARM STOP BEDWETTING

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 08/23/2019

Event Type  Injury  

Event Description

My son is (b)(6) years old and was using a nitehawk bedwetting alarm.But it broke and we purchased the malem alarm with high expectations.The alarm is defective and dangerous.When i inserted batteries, it appeared to be fine.Then i plugged in the cable portion which detects urine and that is when the problems started.The alarm gets hot.My son wore it as soon as i set it up and went to bed.He came to me 20 minutes later saying that he took off the malem alarm because it was hot and burning him.I checked and it was not hot, but extremely hot.I was scared it would catch fire and i put it in the attic.Checked back an hour later and smelled like melted plastic.The alarm was covered in battery liquid.Too dangerous and not for children.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALAM MEDICAL LTD.
• MDR Report Key: 8944576
• MDR Text Key: 156097257
• Report Number: MW5089417
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM STOP BEDWETTING
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR