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

Model Number M08

Device Problems Overheating of Device (1437); Gas/Air Leak (2946); Material Deformation (2976)

Patient Problem Irritation (1941)

Event Date 06/29/2018

Event Type  Injury  

Event Description

Malem bedwetting alarm got hot and short circuited the batteries.Batteries leaked on child's skin and caused irritation.I washed the area with warm water and soap to neutralize it.The bedwetting alarm also got very hot and now is unusable.The housing that holds the batteries has deformed from excess heat.

• Brand Name: MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7658164
• MDR Text Key: 113163244
• Report Number: MW5078192
• 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: 06/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M08
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR