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

Model Number M042

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  Injury  

Event Description

I just placed the alarm on my daughter 20 minutes ago before she went to sleep and she woke up and said that she cant sleep cause the alarm is too hot.Yes, it is too hot to operate.Smells like burning plastic.I think its short circulating.I have removed the batteries because i am worried that the alarm will get even more hot.In 20 minutes, it was so hot i could not even touch it to open and remove the batteries.My daughter is not hurt or injured, but could have been hurt badly.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 9516440
• MDR Text Key: 172889671
• Report Number: MW5091867
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Lot 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: 6 YR