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

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2018

Event Type  Injury  

Event Description

Just a few mins ago, my son came in and said that the enuresis alarm he has been using for last 3 days is acting very strange.The alarm is getting hotter than normal and it woke him from his sleep.I removed the alarm and it was warm.Now, after about 30 mins, the alarm got very hot and batteries inside the alarm leaked out.Like a dangerous explosion in the device.This is very risky for children.If my son had not reached out to me, it could have been very scary.This alarm is new and only used for 3 nights.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7956052
• MDR Text Key: 123506266
• Report Number: MW5080452
• 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: 10/08/2018

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: M04
• Device Catalogue Number: ULTIMATE ALARM SELECTABLE TONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR