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

Model Number ULTIMATE PRO

Device Problems Fire (1245); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Last night, the bed wetting alarm was used for the first night.The alarm caught fire from batteries and burnt through the bed sheet.The batteries were the ones supplied by the company.Instructions were followed.Fortunately no one was wearing the alarm at the time of the incident.The plastic on the alarm melted from heat.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: 10232498
• MDR Text Key: 197558147
• Report Number: MW5095349
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO
• 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: 7 YR