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

Model Number M04S

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Burn, Thermal (2530)

Event Date 01/13/2019

Event Type  Injury  

Event Description

My daughter has suffered burn injuries to her neck with a malem alarm.She was asleep and the alarm burnt her.She managed to remove the alarm , but a bit late.It has already burnt her skin a little bit.This is not how it is supposed to work.We are terrified and worried about the alarm and what has happened.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CODITIONED, RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 8260667
• MDR Text Key: 133831599
• Report Number: MW5083212
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR