MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE, ENURESIS

Model Number CAMO COLOR

Device Problems Leak/Splash (1354); Overheating of Device (1437); Battery Problem (2885); Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2017

Event Type  Injury  

Event Description

Our daughter was using the malem bed wetting alarm.This was the first time we used the alarm.It was purchased from (b)(6) and arrived 1 day earlier.The alarm was brand new and came with all parts.All we did was insert batteries in the alarm unit and insert the sensor.Next, i placed on my daughter and put her to bed.That was it.Within an hour, the alarm got hot so she took it off, but when we turned on the light, we noticed that the batteries had spilled on to her clothing and body.The alarm had somehow shorted out and caused batteries to leak on her body.We stopped using the product immediately.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 6989830
• MDR Text Key: 90748432
• Report Number: MW5073031
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAMO COLOR
• 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: 6 YR