MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M05SC

Device Problems No Audible Alarm (1019); Leak/Splash (1354); Melted (1385); Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 04/01/2019

Event Type  Injury  

Event Description

Powered up the malem alarm by inserting batteries and then plugged in the sensor.Immediately the alarm started to vibrate but not make the alarming sound.I thought something was wrong and removed the sensor.That fixed it, but when i reconnected the sensor, this time, nothing happened.The alarm was not vibrating.Assuming that the vibration was an error on my part.I proceeded to place the alarm on my son ((b)(6)) and sat besides him as he went to sleep.He complained 15 mins later that the alarm was stinging him like it was on fire.I rechecked and it was hot, actually very hot.I removed the sensor and waited for 5 mins.The alarm cooled down.Then i reconnected the sensor and placed it on my son.Again, 15 mins later, he was complaining that he was feeling a hot object touching him.I left the sensor stay in place and removed the alarm from my son.I placed on the side of the bed and when i checked 30 mins later, the alarm back had melted from heat and batteries had leaked out of the bedside of the alarm.Fortunately my son did not get burnt or electrocuted.He was only experiencing a burning sensation from the hot alarm pressing against his skin.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8487416
• MDR Text Key: 141186805
• Report Number: MW5085616
• Device Sequence Number: 0
• Product Code: KPN
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05SC
• Was Device Available for Evaluation?: Yes
• 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