MAUDE Adverse Event Report: MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Burn(s) (1757)

Event Date 02/19/2018

Event Type  Injury  

Event Description

I am disappointed over how a small bedwetting alarm can burn a child in the middle of the night.That is exactly what happened with my son's malem alarm.He was asleep and when i went to check on him an hour or so later, i noticed that the alarm had black stick substance coming out from it.This was a battery leak.I immediately removed the alarm and in the process, burnt my fingers.The alarm was so hot that it was hard to hold it.Fortunately my son was wearing a thick sweater, so nothing happened to him.This was a fresh alarm just purchased and first night of use.The batteries were the ones that came with the alarm.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7302238
• MDR Text Key: 101245759
• Report Number: MW5075545
• 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: Other
• Type of Report: Initial
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• 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: 8 YR
• Patient Weight: 26