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

Model Number M05RB - BLUE

Device Problems False Alarm (1013); Overheating of Device (1437); Defective Device (2588); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

We are facing a strange situation with malem alarm.It was purchased last week from the website www.Bedwettingstore.Com.They said that the malem was a reliable alarm for my son.The first week, it worked erratically, going off for no reason and waking up my son and me even when he was dry.But tonight, it's acting strange.We let the batteries stay inside the alarm and connect the sensor.When the sensor is connected, the alarm forces vibration like something is stuck inside.It's hissing and making strange sounds also.The alarm is warming up.I removed and replaced the batteries but it's doing this.The vibration is acceptable, but the warming up is what worries me.It's going from room temperature to warm to hot and very hot.I worry that it may just get very hot that it may pose a risk to my son.So i have stopped using it and reporting this to fda.Even after charging 4 pairs of batteries, the device is getting hot.Not normal and quite dangerous for a (b)(6) kid to use.

• Brand Name: MALEM ULTIMATE RECORDABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8041811
• MDR Text Key: 126508677
• Report Number: MW5081046
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M05RB - BLUE
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 21