MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problems Leak/Splash (1354); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2017

Event Type  Injury  

Event Description

This is the fourth night that my daughter has used the malem alarm.The first night, the alarm was set up on her with the alarm on her t-shirt top and the sensor on her underwear.That night, my daughter complained that the alarm was warming up and bothered her.I removed it and felt the same on my palm.The alarm was really hot.It could easily have caused a minor burn.I removed it from her and removed the batteries.The next day, i tried with fresh batteries and set my daughter to bed.An hour later, she complained that the alarm was warming up again.I promptly removed the batteries and did not use it the third night.The fourth night, i put in fresh batteries and set it up on my daughter.Once again, an hour later, she complained that the alarm was warming up.This time, i removed it and forgot to remove batteries from the alarm.I kept the alarm on the side of my bed and put my daughter to sleep.About 3 minutes later, the alarm made a clicking sound and kept doing it for a few minutes and then stopped.I looked closely and noticed that the batteries inside the alarm had leaked out.This is an issue with the product.If my daughter were using the alarm, it would have spilled the chemicals on her neck and who knows even burnt her.I am surprised this happened.I am glad i didn't force my daughter to use it.Batteries spilling on her body could be very dangerous and could harm her.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6879300
• MDR Text Key: 86976390
• Report Number: MW5072224
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR