MAUDE Adverse Event Report: MALEM MALEM ENURESIS ALARM

Model Number M048TEC

Device Problems Bent (1059); Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 03/25/2018

Event Type  Injury  

Event Description

This past weekend, my boy was sleeping in bed with his bedwetting alarm.At night, the alarm just exploded while he was in bed and leaked out very hot and deadly battery fluid on his body.He was burnt very badly from the battery leak and the over-hot plastic of the alarm.He has had to take first aid treatment in hospital and is still getting treatment even after nearly 1 week.The hot alarm and battery fluid have scarred and left a big red patch on his neck.He is in extreme pain.The heat also bent the plastic door of the malem alarm.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM; nottingham, gb
• MDR Report Key: 7391582
• MDR Text Key: 104268019
• Report Number: MW5076257
• 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: 03/29/2018

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: No Information
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2018
• 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