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

Model Number ULTIMATE ALARM (SELECTABLE)

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

This is a brand new malem ultimate bedwetting alarm which is defective.First night of use, the alarm self destructed.I inserted batteries and sensor and was getting my daughter when the alarm got hot and batteries just leaked out of it.The alarm was hot and stinking of burning plastic.I am fortunate it did not injure my daughter.Just a big scare for us.New alarm, did nothing, just powered it up.That's it.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 8691780
• MDR Text Key: 147894493
• Report Number: MW5087274
• 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: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTIMATE ALARM (SELECTABLE)
• Device Catalogue Number: DARK BLUE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR