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

Model Number MALEM ULTIMATE RECORDABLE

Device Problem Temperature Problem (3022)

Patient Problem Discomfort (2330)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

We received the malem bedwetting alarm in the mail earlier today.We set it up as per the instructions.The alarm is not operating as expected right out of the box.It came with batteries, but the alarm is getting very hot when i insert the sensor and it starts beeping.I can understand the beeping and the vibrating that it's doing, it's normal, but it doesn't sound normal for it to get hot.This is hot that it's hard to hold in the hands.I removed the sensor and still it keeps getting hot.The only way to deal with this is to actually remove batteries.I am not certain how a child can sleep with so much heat being generated.This is definitely a device malfunction.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7776525
• MDR Text Key: 117008326
• Report Number: MW5079054
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MALEM ULTIMATE RECORDABLE
• Device Catalogue Number: M05R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 6 YR
• Patient Weight: 24