MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number

Device Problems Bent (1059); Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Date 06/03/2018

Event Type  Injury  

Event Description

Purchased two malem alarms for my children.One of the alarm malfunctioned while one of my boys was asleep.By malfunction i mean it's short circuited out at night and that caused the system to overheat and caused batteries to explode.The end result was that the battery acid leaked on my child's body and neck and stained his clothing.The back causing of the alarm portion was deformed by the heat and bent inwards.All of these have had a detrimental effect on my child.He refuses to cooperate and use the alarm now for his bedwetting.He was able to remove the alarm safely before any further harm was caused, but if not, he would be burnt rather badly.My other son's alarm has also demonstrated a similar effect where it gets extremely hot to touch.The alarms are not appropriate for young children as they have a design flaw in my opinion making them dangerous to operate at night when children sleep.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 7590815
• MDR Text Key: 110774301
• Report Number: MW5077742
• Device Sequence Number: 2
• 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: 06/09/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information

Device Model Number

• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 20