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

Model Number ULTIMATE ALARM

Device Problem Overheating of Device (1437)

Patient Problem Sleep Dysfunction (2517)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

The malem bedwetting alarm (ultimate alarm) is getting hot when my son is sleeping with it.He complains that the heat is unbearable and it is disturbing him at night.I removed it after 20 mins and checked it.It is just too hot to use.It's touching him and he complains that this is very hot.Replaced the batteries with (b)(6) brand and it's getting just as hot.The heat is like touching a hot iron rod.Can't be used safely.Have to report device malfunction as it is unsafe and unfit for a (b)(6) child.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8649771
• MDR Text Key: 146474447
• Report Number: MW5086935
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18