MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; ENURESIS ALARM

Model Number M04S

Device Problems Overheating of Device (1437); Material Deformation (2976)

Patient Problem Burn, Thermal (2530)

Event Date 07/15/2018

Event Type  Injury  

Event Description

Parents brought in their (b)(6) son last night.The boy had suffered minor burns from a bedwetting alarm which had overheated during normal operation.Parents said that the alarm was new and received over the weekend and this was the first night it was used.The alarm had become very hot and the casing had deformed from heat.Parents took back the enuresis alarm.The child had very minor burns on his neck from skin contact with the enuresis alarm.We treated him and was discharged 30 minutes later.This is the third such case of burns with an enuresis alarm from the same brand that we have encountered.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham, gb ; UK
• MDR Report Key: 7705757
• MDR Text Key: 114698972
• Report Number: MW5078475
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/16/2018

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?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 24