MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number M04SC

Device Problems Leak/Splash (1354); Melted (1385); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 07/16/2017

Event Type  Injury  

Event Description

The bedwetting alarm acted up last night and got very hot.The batteries leaked out from the alarm and battery door melted.My daughter has barely put it on herself for 15 minutes when this happened.If she was asleep when this happened, it could have caused serious problems.There are very minor burns on her neck because of the alarm.It's not a safe product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6724553
• MDR Text Key: 80508169
• Report Number: MW5071074
• 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: Other
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SC
• 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