MAUDE Adverse Event Report: MALEM BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 12/20/2017

Event Type  Injury  

Event Description

A brand new malem bed wetting alarm which was purchased less than a week ago has injured my son.The alarm was taken out of the box last night and used exactly as instructed with the batteries that came with the alarm.Within 45 minutes of use, the alarm got extremely hot and short circuited the batteries.The plastic that holds the alarm melted at the back and all the battery matter leaked on my son's neck and chest and hands.I had to take him to the hospital for treatment.He was given first aid and a wash and discharged.

• Brand Name: BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7145484
• MDR Text Key: 95803935
• Report Number: MW5074203
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR