MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL; ALARM CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Overheating of Device (1437); Battery Problem (2885)

Patient Problem Burn, Thermal (2530)

Event Date 07/04/2018

Event Type  Injury  

Event Description

Parents have complained that the child's enuresis alarm has burnt child in neck.The alarm was operated correctly and it appears that the alarm generated too much heat as a result of a malfunction which is likely the result of batteries shorting.The heat was immense and has burnt child's neck.The alarm portion of the device has bent from the heat.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7673351
• MDR Text Key: 113625285
• Report Number: MW5078290
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 4 YR
• Patient Weight: 22