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

Model Number M042

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 06/01/2019

Event Type  Injury  

Event Description

Last night, my son used his bedwetting alarm for the first time and it was a scary experience for us.I know how these alarms work and i set it up as it's supposed to be and put my son to sleep.He was put to bed and just within 30 mins, i heard him screaming in pain.My wife and i rushed in to find him crying, trying to remove the alarm.It was hot.I had to use a towel to remove it and in the process, my son was also hurt.The alarm was so hot that my son's skin was burnt.The alarm is unusable now.The internal electronics have likely burnt from heat.Will never use this alarm again.Fda safety report id#(b)(4).

• Brand Name: ULTIMATE MODEL ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 8674629
• MDR Text Key: 147314745
• Report Number: MW5087145
• 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: 06/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR