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

Model Number ULTIMATE RECORDABLE ALARM

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Overheating of Device (1437)

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

Event Date 02/02/2019

Event Type  malfunction  

Event Description

This malem alarm did not work.I took it out of the box, put in batteries, had the light flash that there was power, and then hooked it up to a damp cloth to test it.Nothing.I tried all three modes - vibrate with alarm, just alarm and just vibrate.I got nothing all three times.The sensor connection to the box is very loose and jiggly.The whole thing looks and feels cheap.But it gets hot when i put a damp cloth.I was holding it in my hand all the time trying to see how it works, and within 10 minutes, the alarm got hot.I was unsure what caused it and removed the sensor.It cooled down.Then again when i inserted the sensor, within 10 minutes it started getting hot.I placed it on the side and returned after an hour to find a burnt unit.Batteries leaked and spilled on the table.How can i use this on a child who is only (b)(6)? it will just burn him when he is sleeping.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8320483
• MDR Text Key: 135881827
• Report Number: MW5083838
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE RECORDABLE ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR