MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 12/02/2017

Event Type  Injury  

Event Description

This report is with the malem bedwetting alarm which was purchased as brand new from the mfr's website.The alarm was received in (b)(6) and shipped from the (b)(4).It came with 2 batteries which were inserted correctly to power on the product.Within just a few minutes of batteries being inserted, the alarm started ticking.Something was stuck inside the alarm.But since the ticking was very faint, i ignored it and set it up on my daughter.The alarm started getting very hot and when i checked back on her about 15 mins later, she was complaining that it was too hot to wear.I checked on this and indeed it was very hot.I removed the alarm from her shirt and sensor from panties and in the process, i even burnt my fingers.I placed the alarm on the nearby desk and removed the sensor.The ticking sound continued.About 15 mins later, the alarm stopped ticking.I noticed that the back door that holds the batteries in place had melted (partially) from the heat and batteries had leaked out completely.There was black liquid on the desk.This could have been a very dangerous thing if i had landed on my daughter's body.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 7087288
• MDR Text Key: 94120549
• Report Number: MW5073789
• 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: 12/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 22