MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Material Deformation (2976); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Burn, Thermal (2530)

Event Date 02/23/2018

Event Type  Injury  

Event Description

Our daughter's malem bedwetting alarm malfunctioned just as we put in on her.This was the first time that the alarm was used.It was purchased brand new from (b)(6).The batteries were inserted as instructed but within a few mins, the alarm started clicking and then started getting hot.Unfortunately our daughter was wearing the alarm when the accident happened.She was asleep.The alarm got very hot and the heat somehow short circuited the batteries inside the alarm part and leaked out.Also, the heat was deformed the plastic part that holds batteries in place.The alarm unit leaked batteries on her clothes and hands.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 7299524
• MDR Text Key: 101129177
• Report Number: MW5075526
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/23/2018

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: 02/26/2018
• 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: 5 YR
• Patient Weight: 20