MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ALARM FOR BEDWETTING CHILDREN; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

We received a bedwetting alarm today.It is the malem brand for my son and i bought it for my son at the recommendation of his pediatrician.I installed batteries in the alarm and was getting ready to use it on my (b)(6) year old son, within 45 minutes, the alarmed stopped working.It was kept on the bed and when i picked it up, i noticed that the alarm was hot and there was battery acid on the bottom.Something caused this new device to get hot and short out the batteries.We did nothing.Just installed batteries and the device blew up by itself.

• Brand Name: MALEM ALARM FOR BEDWETTING CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8294012
• MDR Text Key: 135691956
• Report Number: MW5083602
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• Device Catalogue Number: SELECTABLE 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: 5 YR