MAUDE Adverse Event Report: MALEM MALEM ENURESIS ALARM

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problems Bruise/Contusion (1754); Chemical Exposure (2570)

Event Date 09/26/2017

Event Type  Injury  

Event Description

This is a horrible product and one that is risky to use as well.I put in batteries in the malem alarm and was ready to set it up on my son at night before he went to bed.He was changing and using the bathroom and within that time, the alarm started making a click and hiss sound and as it lay on the table, the batteries leaked out.My son didn't realize it and picked up the alarm and placed it on his t-shirt.As he did, the battery acid and spilled out on his clothing and hands.He has had minor bruises from the battery liquid on his finger tips and palm of his hands.It was only there for a few seconds.I am surprised how this alarm can be so dangerous and split batteries.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6903545
• MDR Text Key: 87854659
• Report Number: MW5072521
• 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: 09/27/2017

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: 09/29/2017
• 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