MAUDE Adverse Event Report: BEDWETTING STORE MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/20/2017

Event Type  Injury  

Event Description

I purchased the malem bedwetting alarm from the (b)(6).(b)(6).Within just a week of using it the alarm overheated and burnt my son's neck.When i mean burnt i mean burnt, not just some kind of redness.The alarm overheated and the plastic on the back of the alarm had melted and this melted plastic ate through my son's skin on his neck.We rushed him to the emergency room where he was there for one night.Who is going to pay my bills and who will compensate my son for his pain.Any answers.I noticed a bunch of complaints on maude, then why is this company still selling their alarms in the us.The malem alarms are like hot pots sitting in households, when they can get hot and burn a child is just a matter of time.Take action soon before another child gets burnt.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): BEDWETTING STORE
• MDR Report Key: 6685799
• MDR Text Key: 79140693
• Report Number: MW5070778
• 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: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Hospitalization