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

Model Number M042

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Our brand new bedwetting alarm has abruptly stopped working and in the process become dangerous to use.I said it up and it was sitting on my lap.After 15 mins (could be 30) i felt something very hot on my skin and bad smell.I picked up the alarm from my lap and it was super hot.My fingertips got burnt in the process of picking up the alarm from my lap.Also, there was sticky liquid coming out from the alarm.It was the batteries leaking.After 5 mins, my hands were black from a reaction to the battery spill on my hands and lap.The alarm stopped working and on opening the battery section.I could see leaked batteries.Overall a dangerous and scary experience for me, my daughter who was to use this in her sleep is (b)(6) she would be in pain and serious problem if this happened when she was asleep.Fda product 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: 8727330
• MDR Text Key: 149171308
• Report Number: MW5087556
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR