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

Model Number ULTIMATE SELECTABLE

Device Problems Fire (1245); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2019

Event Type  Injury  

Event Description

I put in brand new batteries right out of the package and my malem started on fire.It was hot and smelling of burning plastic.It was hot.I could not open it.Had to wear oven mitts and place it in bath tub under water to make temperature go down.Very dangerous.Thankfully son was not wearing it when incident happened.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8911077
• MDR Text Key: 154905422
• Report Number: MW5089157
• 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: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE SELECTABLE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR