MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M05

Device Problems Melted (1385); Overheating of Device (1437); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  Injury  

Event Description

My daughter used the alarm last night.She has been using it for 2 weeks now.Last night suddenly in the middle of the night, i heard a hissing sound.I slept with my daughter in bed.I woke up and heard a ticking sound coming from the alarm.It appears that the vibration part of the alarm got stuck and was clicking.As it clicked, the unit started overheating to a point where the back of the alarm unit melted.I was fortunate to take the alarm away from my daughter or it would have seriously harmed her as this is placed so close to her neck.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 5624441
• MDR Text Key: 44237745
• Report Number: MW5062003
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Device Catalogue Number: M05
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR