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

Model Number M031

Device Problems Leak/Splash (1354); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 10/03/2018

Event Type  Injury  

Event Description

We tried to use the malem alarm but were unsuccessful after the alarm malfunctioned.Something inside the alarm keeps rattling when it is turned on (batteries inserted) and gets more intense when the sensor is connected.Our daughter was asleep with the alarm connected per directions and the sensor on her underwear.She was frightened when the alarm got noticeably hot in about 30 mins after she went to sleep.It was bothering her and she removed it.By the time we reached to it 15 mins later, it had become very hot and the batteries were leaking out from the backside of the alarm.Our daughter escaped from getting hurt.She was lucky she removed it on time or it would have been dangerous.

• Brand Name: MALEM ORIGINAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7946727
• MDR Text Key: 123213530
• Report Number: MW5080395
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M031
• Device Catalogue Number: RED
• Device Lot Number: SINGLE TONE
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 20