MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARM; ENURESIS ALARM / ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/10/2018

Event Type  Injury  

Event Description

Our clinic has treated an (b)(6) boy whose neck came in contact with a malfunctioned malem bedwetting alarm.The boy's parents had set up the alarm while the child slept at night.They have said that the alarm exploded at night from heat and burnt the boy's neck.The alarm clearly showed signs of overheating, battery leak and a short circuit in the electrical components.

• Brand Name: MALEM ALARM
• Type of Device: ENURESIS ALARM / ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7973358
• MDR Text Key: 124080697
• Report Number: MW5080582
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 42