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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385)

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

Event Date 12/02/2019

Event Type  Injury  

Event Description

I put in brand new batteries right out of the package (b)(6) and my malem bedwetting alarm caught fire.The plastic melted and there was smell everywhere.All i did was insert batteries and plug in the sensor.Plugging in the sensor made the alarm burn up.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9410294
• MDR Text Key: 169060900
• Report Number: MW5091403
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: M042
• 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): Life Threatening
• Patient Age: 4 YR