MAUDE Adverse Event Report: MALEM MALEM BED WETTING ALARM

Model Number MOS4

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 06/09/2017

Event Type  Injury  

Event Description

My (b)(6) daughter was using the malem alarm at night when the alarm unit got extremely hot and burnt her at night.She was old enough to pull it off but there are burn marks on her neck now.Although they are minor marks, they should not have been there in the first place.I am extremely upset with the poor quality of this dangerous product.I have returned the product to where i purchased it.If my daughter had not removed the alarm, it would be disastrous.The back plastic cover of the alarm melted from heat and batteries have leaked out completely.Very dangerous.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6683884
• MDR Text Key: 79037368
• Report Number: MW5070749
• 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
• Type of Report: Initial
• Report Date: 06/29/2017

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: MOS4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR