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

Model Number M04

Device Problems Fumes or Vapors (2529); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 09/16/2018

Event Type  Injury  

Event Description

The father of a (b)(6) boy came in to get treatment for his child.The child was prescribed an enuresis alarm by a pediatrician and the parents purchased a new one from the mfr's website.Last night was the first time the parents used the enuresis alarm.They set it up as the instructions said; however, the alarm has malfunctioned and burnt the child severely in the neck.Parents have said that the enuresis alarm somehow got very hot and had fumes coming from the inside while the outer casing got hot and burn the child's skin.The parents took the boy to emergency room (er) and had him treated for burns.The alarm is in the possession of parents.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL ; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7885007
• MDR Text Key: 120697596
• Report Number: MW5079844
• 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: 09/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 20