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

Model Number M04S

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

Patient Problem No Code Available (3191)

Event Date 12/16/2017

Event Type  Injury  

Event Description

I was told to purchase a malem bedwetting alarm for my son.I did that and bought one from the internet.The alarm was purchased new and it arrived last week.I immediately went online to see the set up videos and instructions.It is very simple.I inserted batteries in the product (the batteries came with the malem alarm) and clipped the sensor on my son's underwear.Then i connected the sensor and the alarm part.As soon as i did that, the alarm made a buzzing sound from inside.That looked suspicious so i removed it from my son's clothing and took out batteries and restarted everything.Once again it made the buzzing sound.I thought that this was normal and let it go.I checked back on my son about 30 mins or so later, i noticed that the alarm had leaked out the batteries and the batteries had stained his clothing.Some battery acid also leaked on to his body.It was stinking and on the warm side.I woke up my son and removed the alarm.It kept leaking batteries and was hot.About 10 mins or so later, the alarm back part melted from the heat.My son was fine with no injuries, but it could have very serious had he been burnt by the alarm or had the battery and entered his mouth.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 7142042
• MDR Text Key: 95734923
• Report Number: MW5074171
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• 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): Other; Required Intervention
• Patient Age: 5 YR