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

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/10/2018

Event Type  Injury  

Event Description

I am reporting an adverse incident with my son's new malem bedwetting alarm.The alarm malfunctioned during the early hours of the morning when he was asleep.I was sleeping right bedside him and i smelled something strange and noticed that the malem alarm was leaking batteries and there was the smell of burning plastic coming from the alarm.I immediately pulled it off of my son and in the process burnt my fingers.The alarm somehow managed to get very hot and batteries within the alarm leaked on to my boy's clothes.Fortunately no one was hurt.

• Brand Name: MALEM ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7523376
• MDR Text Key: 108571099
• Report Number: MW5077274
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 19