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

Model Number M04SC

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

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

My son's bedwetting alarm has had a serious malfunction before we used it.This is a brand new alarm which was purchased from (b)(6) and was used for about 1 hour.All i did was insert batteries and turn on the alarm.When i came back an hour later, there was battery acid leaking down the table where the alarm was sitting.It was extremely hot and i could not even touch it.This could have hurt my son at night.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7344553
• MDR Text Key: 102724312
• Report Number: MW5075881
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR