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

Model Number M042

Device Problems Deformation Due to Compressive Stress (2889); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Date 05/21/2019

Event Type  Injury  

Event Description

Suffered a major scare last night when the enuresis alarm burnt my daughter.She was asleep in bed when the incident occurred.This was the first night the alarm was used.Appeared normal and worked normally till it short out and when she was sleeping injured her.The alarm was removed and she was so scared, so were we.This is a battery operated alarm and its surprisingly how this could have happened.Gave her a warm water bath.Alarm is not working anymore.It is unusable and slightly deformed from the heat.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8645984
• MDR Text Key: 146410238
• Report Number: MW5086923
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model 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): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 21