MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437); Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 12/20/2016

Event Type  Injury  

Event Description

Purchased the malem alarm in gold color with 8 random tones from (b)(6).The alarm was shipped form the usa to (b)(6) and when it arrived, things worked well for the first two days.My son woke up to the alarm and one night, as i was putting the alarm on him, the alarm started clicking and hissing.It did that for 4-5 seconds and stopped.I put the alarm and he went to sleep.In the middle of the night, my son woke up crying and came to my room.He has a small red patch on his chest where the alarm was clipped.I found the alarm and noticed that the back of the alarm which houses the batteries had overheated and the batteries had leaked.We used neosporin and took him to the doctor next morning.The company was informed of the incident and they promised to refund my money.It's been nearly 4 months and over a dozen phone calls.Still have not received a refund from them.This is ridiculous.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6459733
• MDR Text Key: 71843607
• Report Number: MW5068885
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• 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): Other
• Patient Age: 4 YR