MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/28/2017

Event Type  Injury  

Event Description

Another day, and another problem with the malem bedwetting alarm.The last 4 nights we have used the alarm, it keeps getting hot every time we put batteries in it.This is the second alarm we purchased.The first one also got hot and we thought it was a defect and returned it back to amazon (from where it was purchased).The second one arrived last week and has been used 4 times.Every time we put batteries inside the alarm, it starts to get hot.This doesn't appear to be normal, but the second alarm also doing this was confusing.Last 4 nights, i changed batteries and every time, the same thing continued.Keeps getting hot.Tonight, the batteries sat in there for 30 minutes and the alarm got so hot that i could not even lift it up without burning my fingers.Had to force open the back part to remove the batteries.Just decided to report that this could have burnt my son if he had work it and gone to sleep.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7156780
• MDR Text Key: 96228618
• Report Number: MW5074308
• Device Sequence Number: 2
• 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: Other
• Type of Report: Initial
• Report Date: 12/28/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 3 YR