MAUDE Adverse Event Report: BEDWETTING STORE MALEM BED WETTING ALARM

Model Number ULTIMATE BED WETTING ALARM

Device Problems Unintended Ejection (1234); Melted (1385); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Date 05/09/2017

Event Type  Injury  

Event Description

Tonight, my step daughter installed a malem alarm before bed as she has been in the last 2 weeks.As soon as she clipped it on and inserted the sensor, the alarm made a hissing sound and grey matter came out of the alarm.The back battery melted in a few minutes.Her chest has been burnt and she was taken to the hospital emergency room.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): BEDWETTING STORE; fulton MD
• MDR Report Key: 6562758
• MDR Text Key: 75103769
• Report Number: MW5069701
• Device Sequence Number: 1
• Product Code: KPN
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BED WETTING ALARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 24