MAUDE Adverse Event Report: MALEM MEDICAL MALEM

Model Number M04S

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

Patient Problem Chemical Exposure (2570)

Event Date 10/30/2017

Event Type  Injury  

Event Description

Our malem bedwetting alarm uses 2 aaa batteries.We inserted batteries in the alarm unit and set it up at night.My daughter was wearing the alarm at 9pm pst and she went to bed.About 30 minutes ago at 11:30pm, the alarm started acting up and batteries leaked out of the alarm onto my daughter's clothing.I was quick to notice it as we sleep in the same room and quickly pulled the alarm off from her.The battery continued to leak out for next 2-3 minutes.The alarm has heated significantly.It is not a battery defect, but an alarm issue.Either the alarm is shorting the batteries out or the alarm has some other mechanics that is failing.Either way, this is a problem.

• Brand Name: MALEM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6995727
• MDR Text Key: 90944480
• Report Number: MW5073076
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• 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