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

Model Number M04S

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 04/25/2019

Event Type  Injury  

Event Description

After 2 failed attempts with the malem alarm, i am forced to file the complaint.My son was diagnosed with nocturnal enuresis and his pediatrician recommended the use of an enuresis alarm.I purchased the malem ultimate bedwetting alarm and used it exactly how it was to be used.The problem with the alarm was that it was getting hot.Every time i placed batteries, the alarm got hot.I contacted the mfr and they told me to discontinue use as this could be a potential safety issue.I shipped this alarm to them and they shipped a new one to me.It was the exact same alarm that they shipped back (model m04s - magenta).This one did not get hot when i inserted batteries.But when my son slept, it burnt him at night.He removed the alarm and i immediately treated him with over the counter anti-burn cream (aquaphor healing ointment).The alarm is no longer working.It has burnt the inside and the magenta plastic is bent from excess heat.My son has small red patches from the alarm touching his skin and is recovering.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; UK
• MDR Report Key: 8573504
• MDR Text Key: 143957785
• Report Number: MW5086324
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Device Catalogue Number: MAGENTA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• 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: 20