MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ALARM, ENURESIS

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2017

Event Type  Injury  

Event Description

Just set up our malem alarm and inserted batteries.The alarm got hot in minutes.Removed batteries and reinserted.Same thing.Replaced batteries.Let it sit on table and the alarm just got so hot that the back plastic battery door melted and the batteries leaked out from the back.Thankfully my son wasn't wearing it.

• Brand Name: MALEM
• Type of Device: ALARM, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6686027
• MDR Text Key: 79150481
• Report Number: MW5070784
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2017
• 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