MAUDE Adverse Event Report: MALEM MEDICAL, LTD BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE, ENURESIS

Model Number M04

Device Problems Thermal Decomposition of Device (1071); Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Battery Problem (2885); Material Deformation (2976); Temperature Problem (3022)

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

Event Date 04/02/2019

Event Type  Injury  

Event Description

Horrible alarm, worn for 3 days and on each day, the alarm had to be removed within 30 minutes of connecting it as the alarm would get hot.The alarm would also not power down.Had to take out the batteries to cool it.Replaced batteries many times.Left it on one night on the counter top and the alarm is burnt from inside.Plastic case is deformed from heat.It won't power on.The alarm never activated when wet.Fda safety report id #: (b)(4).

• Brand Name: BED-WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD
• MDR Report Key: 8497091
• MDR Text Key: 141462710
• Report Number: MW5085696
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR