MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Temperature Problem (3022)

Patient Problem Discomfort (2330)

Event Date 01/15/2018

Event Type  Injury  

Event Description

This is the second time i have a problem with the malem enuresis alarm, the first time, i purchased the alarm from (b)(6) so that my (b)(6) boy would stop wetting the bed.The alarm was brand new and when it arrived, i put in batteries and programmed the enuresis alarm.The alarm started to get warm within minutes and about 25 mins later was extremely hot.It was so hot that i could not even hold it in my hand.I was able to remove the batteries and returned it back to (b)(6).I purchased another malem alarm, the exact same one from (b)(6) as well and when that arrived, i tested it first by inserting batteries.Once again, the enuresis alarm got warm immediately but did not get hot.About an hour later, it still seemed warm but not hot so i connected it on my son.He complained 45 mins later that the alarm was bothering him.I noticed that this time, the alarm was once again starting to get very hot and it reached a point where it was again so hot that i could not touch.Fortunately i removed it from my son on time.As the alarm sat on the bed, it exploded and the batteries that were in the alarm leaked on the bed.If this had leaked on my son, it could have been extremely dangerous.The alarm has been returned to (b)(6) for a refund.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7208981
• MDR Text Key: 97961226
• Report Number: MW5074675
• 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: 01/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR