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

Model Number M05

Device Problems Leak/Splash (1354); Temperature Problem (3022)

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

Event Date 10/15/2018

Event Type  malfunction  

Event Description

This is my third malem alarm that has had the same identical problem.The first alarm i purchased new from (b)(6) and it started acting up when i connected the sensor.It would get hot within mins and then we had to remove batteries and let it cool down.I returned the alarm back to (b)(6) after 2 failed nights and they replaced me another alarm.The second one did exactly the same thing and after testing it for 2 days.I returned it back to (b)(6) and bought the newer updated model.That one was by far the worst in the lot, it not only got hot, but after an hour when i checked in on it, heat had partially melted the back of the alarm.The batteries leaked inside the alarm and oozed out of the underside.For this to happen, the temperature should have gone up, way high to like 170f or so.Very dangerous, i am so upset.This is the third time an alarm with this brand failed like this.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7978690
• MDR Text Key: 124319929
• Report Number: MW5080623
• Device Sequence Number: 2
• 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
• Type of Report: Initial
• Report Date: 10/16/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M05
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR